Normoalbuminuric Chronic Kidney Disease in Type 2 Diabetes

June 3, 2020 updated by: Martina Michael Wadae, Assiut University

Prevalence of Normoalbuminuric Chronic Kidney Disease and Its Risk Factors in Patients With Type 2 Diabetes Attending the Diabetes Center of Assiut University Hospital

  • Assess the prevalence of normoalbuminuric CKD in Type 2 diabetes.
  • Study the risk factors of normoalbuminuric CKD in patients with type 2 diabetes.

Study Overview

Status

Status

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

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

Diabetes mellitus (DM) is considered a major cause of chronic kidney disease (CKD), where about 40% of the diabetics develop diabetic kidney disease (DKD) resulting in albuminuria, reduction of glomerular filtration rate (GFR), or both .

Albuminuria was widely considered the first clinical sign of DKD, therefore, it has been used as a screening test for DKD. However, recent studies showed that a significant number of T2DM patients have a decreased GFR with normoalbuminuria, known as non-albuminuric DKD (NA-DKD) .

The use of albuminuria as an early marker of DKD onset or progression requires a careful interpretation because in diabetics, albuminuria has a great tendency to return to normal spontaneously. Evidence based studies reported that about 18-51 percent of T2DM (followed during 2-10 years) present first with albuminuria turn to normoalbuminurics spontaneously during the period of follow-up .

The United Kingdom Prospective Diabetes Study (UKPDS) reported that some diabetics pass directly from a normoalbuminuria to renal insufficiency (0.1% per year) .

Albuminuria as a marker of glomerular lesion progression has some limitations because of its intra-patient variability and possibility of spontaneous regress (in >50% of the patients with low levels of albuminuria), in contrast with GFR that has low variability and infrequent improvement .

Few of T2DM patients are presented without significant proteinuria but present with renal insufficiency and developed DKD (i.e., estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2), which was defined as normoalbuminuric diabetic kidney disease (NADKD) or diabetic kidney disease without proteinuria where albuminuria does not associate with impairment of kidney function .

The ADA criteria for diagnosis of DKD now involve the presence of eGFR < 60 mL/min/1.73 m2 or the presence of UAE > 30 mg/24 h. In patients with NADKD, the risk factors include obesity, hypertension, high TG levels, sex, smoking, poor glycemic control, and glomerular hyperfiltration which play a role in nephrosclerosis. Macroangiopathy is also prevalent in patients with NADKD .

Intrarenal arteriosclerosis is the main cause of renal impairment in type 2 diabetic patients independent of albuminuria, and this partly cause eGFR decline in these patients. Several studies also suggest that decline in renal function is mainly due to interstitial injury (a pathological change in DN) as compared with glomerular injury .

Normoalbuminuria is associated with Diabetic kidney disease (DKD), which is the commonest cause of end-stage renal disease (ESRD) all over the world. The clinical manifestations of DKD consist of a progressive increase in albuminuria and a decline in estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2. Hence, the diagnosis of DKD in patients with declining renal function without albuminuria is more difficult. The decline of renal function is slower in normoalbuminuria .

Tthe majority of patients with DKD had albuminuria, but a significant proportion had the normoalbuminuric renal impairment (46.6%) . The prevalence of NADKD ranges globally from 14.29 to 56.6% among diabetic patients with different ethnicities .

The prevalence of NADKD is about 23.3% to 56.6% in T2DM patients with a decline in the renal function presented with normal albuminuria . However, the prevalence at which the patients develop normoalbuminuric renal impairment in Type 2 diabetes are not completely defined.

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 (Anticipated)

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.
200

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.

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with type 2 diabetes attending diadetes center of Assiut University

Description

Inclusion Criteria:

  • Patients age >18 -65 years .
  • Diagnosed previously with T2DM.

Exclusion Criteria:

  • Patients with type 1 diabetes,

    • Patients with secondary diabetes,
    • Patients with gestational diabetes
    • Patients with severe acute or chronic hepatic or cardiac diseases.
    • Patients with Past or present history of malignancy .
    • Patients with in need for renal replacement therapy.
    • Patients with other probable causes for CKD.
    • Patients with an active urinary sediment and nephrotic - range proteinuria .

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.
patients with type 2 diabetes
patients with type 2 diabetes and have normal range of albumine in urine and decline in renal functions
Diagnostic test: Albumin creatinine ratio
normal range of albumin in urine in patients with type 2 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
Prevalence of Normoalbuminuric chronic kidney disease
Time Frame: Baseline
The required sample size(200 patients) has been calculated using the EPI info version which achieve power of study 80%.
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.
Assiut University

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 (Anticipated)

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.
December 1, 2020

Primary Completion (Anticipated)

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.
May 1, 2021

Study Completion (Anticipated)

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.
July 1, 2021

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).
March 12, 2020

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.
May 30, 2020

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.
June 2, 2020

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.
June 4, 2020

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.
June 3, 2020

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.
May 1, 2020

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.
  • normoalbuminuric CKD in DM2

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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