Microvascular Changes in OCT-angiography in Type 1 Diabetes Mellitus at the Onset of the Disease and After Optimization of Glycemic Control.

March 15, 2023 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study of the Microvascular Changes in the Retina Measured by Optical Coherence Tomography (OCT) - Angiography in Patients With Type 1 Diabetes Mellitus at the Onset of the Disease and After Optimization of Glycemic Control.

The objective of the study is to evaluate the differences in the retinal microcirculation measured by OCT-Angiography in patients with type 1 diabetes between the diagnosis of the disease and after 3 months of insulin treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

20

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 Locations

  • Spain
      • Barcelona, Spain, 08041
        • Recruiting
        • Hospital de la Santa Creu i Sant Pau
        • Contact:
      • Lleida, Spain, 25198

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with type 1 diabetes who meet all the inclusion criteria and none of the exclusion criteria

Description

Inclusion Criteria:

  • Patients with Type 1 Diabetes at diagnosis of the disease (less than 7 days after diagnosis)
  • Age equal to or greater than 18 years
  • Signature of the informed consent by the patient / legal guardian.

Exclusion Criteria:

  • Metabolic situation of ketosis or ketoacidosis, according to clinical criteria established in the protocol of the Endocrinology and Nutrition Service. The patient will be a candidate once the ketonemia is absent (value <1 mmol / L).
  • Previous diagnosis of dyslipidemia and any previous lipid-lowering treatment
  • Previous diagnosis of hypertension and any previous hypotensive treatment
  • Previous diagnosis of any form of cardiovascular disease, including heart failure.
  • Previous kidney disease, and presence of advanced kidney failure (estimated glomerular filtration rate <60 ml / min)
  • Presence of diabetic retinopathy identifiable by conventional eye fundus or retinography, or other concomitant retinal vascular pathology (hypertensive retinopathy, venous occlusion, arterial obstruction, etc.)
  • History or presence of retinal pathology that may alter its structure and / or the validity of the measurements (retinal detachment, epiretinal membrane, high myopia -understood as an axial length greater than or equal to 26mm measured by "IOL Master" biometry-, neovascular membrane, choroidal tumors, etc.)
  • History of posterior uveitis or retinal vasculitis
  • Glaucoma and neuro-ophthalmological pathology that can alter the neuroretinal structures.
  • Refractive media opacity that prevents a correct acquisition of images and, therefore, their evaluation
  • Dementia or intellectual disability that prevent proper collaboration when acquiring images

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
Intervention / Treatment
Type 1 diabetic patients
Recently diagnosed type 1 diabetes patients
Diagnostic test: Optical Coherence Tomography (OCT) Angiography
Measurement of retinal vessel density and distribution in the macula using new generation OCT device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vessel density
Time Frame: 3 months
Density of retinal vessels and perfusion in the macula
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vessel density
Time Frame: 6 months
Density of retinal vessels and perfusion in the macula
6 months

Collaborators and Investigators

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

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Collaborators

Hospital Arnau de Vilanova

Investigators

  • Principal Investigator: Ignacio Salvador, MD, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 1, 2021

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

May 12, 2021

First Submitted That Met QC Criteria

May 12, 2021

First Posted (Actual)

May 17, 2021

Study Record Updates

Last Update Posted (Actual)

March 16, 2023

Last Update Submitted That Met QC Criteria

March 15, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-RET-2020-69

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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