UK Imaging Diabetes Study Seeing Diabetes Clearly (UKIDS)

November 27, 2025 updated by: Perspectum
Prospective, observational cohort study to cross-sectionally assess the health of multiple organs, using multiparametric abdominal magnetic resonance imaging (MRI) scan, and understand if resulting MRI metrics can predict future clinical events over a period of 5 years, in adult patients with type 2 diabetes lacking history of cardiovascular disease.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This will be a multi-site study adopting a prospective, observational cohort study design. There will be no intervention to the standard of care. Study participants will be enrolled in this study for a total of 5 years, with only 1 month of active participation. Participants will be required to attend a screening visit and 2 study visits. The screening visit will involve a medical review and receiving informed consent based on the participant information leaflet already communicated to the patient, pre-screening. The first study visit- baseline (visit 1) - will involve anthropometric measurements and taking a blood and urine sample in order to perform standard of care measurements for type 2 diabetes at baseline and relevant circulating biomarkers. The second study visit will involve having a multi-organ, multiparametric MRI scan. Both visits will be within 28 days of the screening visit and carried out at local study sites.

MRI metrics of organ health, clinical outcome measurements, blood samples and urine samples will be collected to assess the natural history of diabetes disease progression. Participants will be asked to give consent for access to their medical records held at NHS England and, if available, at their local GP surgery or hospital. Medical records access will include Hospital admissions (Hospital Episode Statistics), and mortality data collected by the Office for National Statistics and provided by NHS England to meet the primary objective. This data will be collected at 1, 3 and 5 years after baseline assessment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
      • Liverpool, United Kingdom, L9 7AL
      • London, United Kingdom
        • Enrolling by invitation
        • Moorfields Eye Hospital NHS Foundation Trust
      • Oxford, United Kingdom, OX3 9BP
      • Oxford, United Kingdom, OX3 9JA
        • Recruiting
        • Hedena Health
        • Contact:
      • Oxford, United Kingdom, OX4 1XB
        • Recruiting
        • St Bartholomew and Hollow Way Medical Practice
        • Contact:
      • Oxford, United Kingdom, OX42LL
    • Oxfordshire
      • Didcot, Oxfordshire, United Kingdom, OX11 0BB
        • Recruiting
        • Woodlands Medical Centre
        • Contact:
      • Eynsham, Oxfordshire, United Kingdom, OX29 4QB
        • Recruiting
        • Eynsham Medical Centre
        • Contact:
      • Farringdon, Oxfordshire, United Kingdom, SN7 7YU
        • Recruiting
        • White Horse Medical Practice
        • Contact:
      • Witney, Oxfordshire, United Kingdom, OX26 6JS
        • Recruiting
        • Windrush Medical Practice
        • Contact:
    • Surrey
      • Redhill, Surrey, United Kingdom, RH1 1EB
    • Swansea
      • Baglan, Swansea, United Kingdom, SA12 7BR
        • Not yet recruiting
        • Swansea Bay University Health Board
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult participants, aged 18 years of age and over with type 2 diabetes lacking history of cardiovascular disease. Recruitment will be carried out from patients identified following diabetes or diabetic retinopathy diagnoses or via self-referral.

  1. Diabetes referral appointments
  2. Diabetic retinopathy referral appointments
  3. Primary care and diabetes clinics - including GP practices
  4. Participant Identification Centres
  5. Diabetes Eye Screening Programmes (DESP)

Description

Inclusion Criteria:

  • Male or female at least 18 years of age and diagnosed with type 2 diabetes, with or without diabetic retinopathy.
  • Participant willing and able to give informed consent for participation in the study.

Exclusion Criteria:

In 12 months prior to consent, evidence of existing cardiovascular event defined as at least one of:

  • myocardial infarction
  • ischaemic stroke
  • hospital admission/discharge for unstable angina
  • heart surgery
  • unstable angina
  • transient ischemic attack
  • The participant may not enter the study if they have any contraindication to magnetic resonance imaging (standard MR exclusion criteria including pregnancy, extensive tattoos, pacemaker, shrapnel injury, severe claustrophobia).
  • Patients with known autoimmune hepatitis, viral hepatitis, Wilson's disease or known significant structural renal tract abnormality.
  • Patients with known alcohol dependency.
  • Any other cause, including a significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the participant's ability to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Type 2 diabetes
Patients with type 2 diabetes, especially individuals who have been diagnosed in the last three years
Other: MRI
MRI is not part of Pathway for patient with type two diabetes.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Baseline liver MR metrics on incidence rate of 5-point MACE (CV death, non-fatal stroke, myocardial infarction, heart failure, hospitalisation for CV causes) in people with type 2 diabetes, without history of CV.
Time Frame: 3 year from baseline
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on cardiovascular clinical outcomes in a patient population with type 2 diabetes without history of cardiovascular disease.
3 year from baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of composite severe renal disease events (renal replacement therapy, renal death).
Time Frame: 1 year from baseline
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
1 year from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of composite severe renal disease events (renal replacement therapy, renal death).
Time Frame: 3 years from baseline
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
3 years from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of composite severe renal disease events (renal replacement therapy, renal death).
Time Frame: 5 years from baseline
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
5 years from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of composite mild renal disease events (incident CKD, change in stage of CKD)
Time Frame: 1 year from baseline
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
1 year from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of composite mild renal disease events (incident CKD, change in stage of CKD)
Time Frame: 3 years from baseline
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
3 years from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of composite mild renal disease events (incident CKD, change in stage of CKD)
Time Frame: 5 years from baseline
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
5 years from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections)
Time Frame: 1 year from baseline
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
1 year from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections)
Time Frame: 3 years from baseline
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
3 years from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections)
Time Frame: 5 years from baseline
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
5 years from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of lower limb amputations
Time Frame: 1 year from baseline
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
1 year from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of lower limb amputations
Time Frame: 3 years from baseline
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
3 years from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of lower limb amputations
Time Frame: 5 years from baseline
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
5 years from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of all-cause mortality
Time Frame: 1 year from baseline
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
1 year from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of all-cause mortality
Time Frame: 3 years from baseline
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
3 years from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of all-cause mortality
Time Frame: 5 years from baseline
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
5 years from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of CV death, liver death, renal death, cancer death, other death
Time Frame: 1 year from baseline
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
1 year from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of CV death, liver death, renal death, cancer death, other death
Time Frame: 3 years from baseline
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
3 years from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of CV death, liver death, renal death, cancer death, other death
Time Frame: 5 years from baseline
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
5 years from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension)
Time Frame: 1 year from baseline
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
1 year from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension)
Time Frame: 3 years from baseline
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
3 years from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension)
Time Frame: 5 years from baseline
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
5 years from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of non-hepatic cancer
Time Frame: 1 year from baseline
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
1 year from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of non-hepatic cancer
Time Frame: 3 years from baseline
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
3 years from baseline
The effect of baseline liver MR metrics (cT1 and fat) on the incidence rate of non-hepatic cancer
Time Frame: 5 years from baseline
The impact of liver fibroinflammation (cT1 from multi-organ MRI) on other diabetes-related outcomes
5 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of 5-point MACE (CV death, non-fatal stroke, myocardial infarction, heart failure, hospitalisation for CV causes
Time Frame: 1 year from baseline
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
1 year from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase with incidence of 5-point MACE (CV death, non-fatal stroke, myocardial infarction, heart failure, hospitalisation for CV causes
Time Frame: 3 years from baseline
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
3 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase with incidence of 5-point MACE (CV death, non-fatal stroke, myocardial infarction, heart failure, hospitalisation for CV causes
Time Frame: 5 years from baseline
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
5 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of composite severe renal disease events (renal replacement therapy, renal death)
Time Frame: 1 year from baseline
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
1 year from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of composite severe renal disease events (renal replacement therapy, renal death)
Time Frame: 3 years from baseline
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
3 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of composite severe renal disease events (renal replacement therapy, renal death)
Time Frame: 5 years from baseline
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
5 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of composite mild renal disease events (incident CKD, change in stage of CKD)
Time Frame: 1 year from baseline
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
1 year from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of composite mild renal disease events (incident CKD, change in stage of CKD)
Time Frame: 3 years from baseline
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
3 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of composite mild renal disease events (incident CKD, change in stage of CKD)
Time Frame: 5 years from baseline
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
5 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections)
Time Frame: 1 year from baseline
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
1 year from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections)
Time Frame: 3 years from baseline
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
3 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections)
Time Frame: 5 years from baseline
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
5 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of lower limb amputations
Time Frame: 1 year from baseline
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
1 year from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of lower limb amputations
Time Frame: 3 years from baseline
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
3 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of lower limb amputations
Time Frame: 5 years from baseline
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
5 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of all-cause mortality
Time Frame: 1 year from baseline
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
1 year from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of all-cause mortality
Time Frame: 3 years from baseline
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
3 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of all-cause mortality
Time Frame: 5 years from baseline
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
5 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of CV death, liver death, renal death, cancer death, other death
Time Frame: 1 year from baseline
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
1 year from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of CV death, liver death, renal death, cancer death, other death
Time Frame: 3 years from baseline
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
3 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of CV death, liver death, renal death, cancer death, other death
Time Frame: 5 years from baseline
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
5 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension)
Time Frame: 1 year from baseline
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
1 year from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension)
Time Frame: 3 years from baseline
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
3 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension)
Time Frame: 5 years from baseline
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
5 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of non-hepatic cancer
Time Frame: 1 year from baseline
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
1 year from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of non-hepatic cancer
Time Frame: 3 years from baseline
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
3 years from baseline
Potential effect of body composition, liver volume, and aortic (distensibility, diameter) MRI metrics increase and incidence of non-hepatic cancer
Time Frame: 5 years from baseline
The impact that liver volume, whole body composition and, abnormalities in the aorta have on diabetes-related clinical outcomes using multiparametric MRI
5 years from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of 5-point MACE (CV death, non-fatal stroke, myocardial infarction, heart failure, hospitalisation for CV causes)
Time Frame: 1 year from baseline
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
1 year from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of 5-point MACE (CV death, non-fatal stroke, myocardial infarction, heart failure, hospitalisation for CV causes)
Time Frame: 3 years from baseline
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
3 years from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of 5-point MACE (CV death, non-fatal stroke, myocardial infarction, heart failure, hospitalisation for CV causes)
Time Frame: 5 years from baseline
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
5 years from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of the composite severe renal disease events (renal replacement therapy, renal death)
Time Frame: 1 year from baseline
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
1 year from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of the composite severe renal disease events (renal replacement therapy, renal death)
Time Frame: 3 years from baseline
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
3 years from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of the composite severe renal disease events (renal replacement therapy, renal death)
Time Frame: 5 years from baseline
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
5 years from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of the composite mild renal disease events (incident CKD, change in stage of CKD)
Time Frame: 1 year from baseline
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
1 year from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of the composite mild renal disease events (incident CKD, change in stage of CKD)
Time Frame: 3 years from baseline
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
3 years from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of the composite mild renal disease events (incident CKD, change in stage of CKD)
Time Frame: 5 years from baseline
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
5 years from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of the retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections)
Time Frame: 1 year from baseline
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
1 year from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of the retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections)
Time Frame: 3 years from baseline
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
3 years from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of the retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections)
Time Frame: 5 years from baseline
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
5 years from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of lower limb amputations
Time Frame: 1 year from baseline
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
1 year from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of lower limb amputations
Time Frame: 3 years from baseline
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
3 years from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of lower limb amputations
Time Frame: 5 years from baseline
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
5 years from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of all-cause mortality
Time Frame: 1 year from baseline
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
1 year from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of all-cause mortality
Time Frame: 3 years from baseline
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
3 years from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of all-cause mortality
Time Frame: 5 years from baseline
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
5 years from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of CV death, liver death, renal death, cancer death, other death
Time Frame: 1 year from baseline
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
1 year from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of CV death, liver death, renal death, cancer death, other death
Time Frame: 3 years from baseline
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
3 years from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of CV death, liver death, renal death, cancer death, other death
Time Frame: 5 years from baseline
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
5 years from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension
Time Frame: 1 year from baseline
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
1 year from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension
Time Frame: 3 years from baseline
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
3 years from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension
Time Frame: 5 years from baseline
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
5 years from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of non-hepatic cancer
Time Frame: 1 year from baseline
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
1 year from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of non-hepatic cancer
Time Frame: 3 years from baseline
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
3 years from baseline
The effect of retinopathy severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR) on the incidence rate of non-hepatic cancer
Time Frame: 5 years from baseline
The impact of the severity of diabetic retinopathy on cardiovascular and other diabetes-related outcomes
5 years from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of 5-point MACE (CV death, non-fatal stroke, myocardial infarction, heart failure, hospitalisation for CV causes)
Time Frame: 1 year from baseline
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
1 year from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of 5-point MACE (CV death, non-fatal stroke, myocardial infarction, heart failure, hospitalisation for CV causes)
Time Frame: 3 years from baseline
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
3 years from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of 5-point MACE (CV death, non-fatal stroke, myocardial infarction, heart failure, hospitalisation for CV causes)
Time Frame: 5 years from baseline
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
5 years from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of composite severe renal disease events (renal replacement therapy, renal death)
Time Frame: 1 year from baseline
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
1 year from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of composite severe renal disease events (renal replacement therapy, renal death)
Time Frame: 3 years from baseline
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
3 years from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of composite severe renal disease events (renal replacement therapy, renal death)
Time Frame: 5 years from baseline
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
5 years from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of composite mild renal disease events (incident CKD, change in stage of CKD)
Time Frame: 1 year from baseline
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
1 year from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of composite mild renal disease events (incident CKD, change in stage of CKD)
Time Frame: 3 years from baseline
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
3 years from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of composite mild renal disease events (incident CKD, change in stage of CKD)
Time Frame: 5 years from baseline
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
5 years from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections)
Time Frame: 1 year from baseline
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
1 year from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections)
Time Frame: 3 years from baseline
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
3 years from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of retinal intervention (photocoagulation, Vity, or use of anti-vascular endothelial growth factor injections)
Time Frame: 5 years from baseline
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
5 years from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of lower limb amputations
Time Frame: 1 year from baseline
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
1 year from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of lower limb amputations
Time Frame: 3 years from baseline
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
3 years from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of lower limb amputations
Time Frame: 5 years from baseline
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
5 years from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of all-cause mortality
Time Frame: 1 year from baseline
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
1 year from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of all-cause mortality
Time Frame: 3 years from baseline
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
3 years from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of all-cause mortality
Time Frame: 5 years from baseline
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
5 years from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of CV death, liver death, renal death, cancer death, other death
Time Frame: 1 year from baseline
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
1 year from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of CV death, liver death, renal death, cancer death, other death
Time Frame: 3 years from baseline
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
3 years from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of CV death, liver death, renal death, cancer death, other death
Time Frame: 5 years from baseline
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
5 years from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension
Time Frame: 1 year from baseline
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
1 year from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension
Time Frame: 3 years from baseline
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
3 years from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of liver events (decompensation, hepatocellular carcinoma diagnosis, transplant, portal hypertension
Time Frame: 5 years from baseline
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
5 years from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of non-hepatic cancer
Time Frame: 1 year from baseline
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
1 year from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of non-hepatic cancer
Time Frame: 3 years from baseline
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
3 years from baseline
The effect of age of T2DM diagnosis (early onset and under 45 year of age, usual onset) on the incidence rate of non-hepatic cancer
Time Frame: 5 years from baseline
The impact of age of onset of T2DM on cardiovascular and other diabetes-related outcomes
5 years from baseline
Prevalence of patients with evidence of metabolic dysfunction-associated steatotic liver disease in patients with diabetic retinopathy of different severity (no DR, mild NPDR, moderate NPDR, severe NPDR, PDR, advanced PDR)
Time Frame: 1 year from baseline
The co-prevalence of diabetic retinopathy (DR) and metabolic dysfunction-associated steatotic liver disease (MASLD), using multi-parametric abdominal MRI
1 year from baseline
Correlations between liver MRI metrics (organ volume, fat infiltration and fibroinflammation) and eye metrics (retinal layer thickness by OCT, discrete retinopathy scores)
Time Frame: 1 year from baseline
The correlation between severity of eye disease and MRI-derived metrics of liver disease using multiparametric MRI
1 year from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Perspectum

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Moorfields Eye Hospital NHS Foundation Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ravi Pattanshetty, Perspectum

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 30, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2034

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2034

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 1, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 27, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 5, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20/WM/0007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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