Incretin-mimetic Hypoglycemic Drugs and Severe Retinopathy

Type 2 Diabetes Clinical Trial

— ANGIOSAFE2  

Official title:

Impact of Incretin-mimetic Hypoglycaemic Drugs on Diabetic Retinopathy in Type 2 Diabetic Patients and Study of Biomarkers in the Development of Severe Retinopathy: Angiosafe-T2D Study 2

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02671864
• Other study ID #: P150601
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 11, 2016
• Est. completion date: April 11, 2025

Study information

• Verified date: March 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Experimental data suggest that GLP-1 promote endothelial cell growth and angiogenesis which may have beneficial effects on the cardiovascular system but harmful effects on the retina . This project investigate the possible link between incretin therapy and Severe Diabetic Retinopathy. The prevalence of severe DR in patients exposed to incretin therapy (GLP-1 analogs or DPP4 inhibitors) is compared to that in non-exposed patients to these antidiabetic classes.

Description:

This study is dedicated to investigate the impact of routinely prescribed hypoglycaemic treatments on the prevalence of severe retinopathy and to seek possible biomarkers of severe retinopathy. Hypoglycemic treatments taken by the patients are those prescribe by the usuel diabetogist in the context of routine care.

The study includes T2D patients according to ADA criteria treated with any kind of hypoglycemic treatment and attending a diabetes center (three in Marseille: Department of Endocrinology, Hôpital Nord, Assistance Publique des Hôpitaux de Marseille and Service d'Ophtalmologie, Hôpital Saint-Joseph and Service de Diabétologie, Hôpital Saint-Joseph, and two in Paris : Centre Universitaire du Diabète et de ses Complications Hôpital Lariboisière, Université Paris 7, Assistance Publique des Hôpitaux de Paris and Service d'Endocrinologie, Diabétologie et Nutrition, Hôpital Bichat).

It consists of two visits: Visits1 "Inclusion" and Visits 2 "three years after the inclusion". In each visit, the investigators will collect results of eye examination (fundus) and annual diabetes check up including anthropometric data, routine biology, diabetes complication status as well as medications taken by the patients (past and current). A bio-banking (blood, urine and hairs) will be also collected. Primary objective : to compare the prevalence of severe DR in patients exposed to incretin therapy (GLP-1 analogs or DPP4 inhibitors) to that in non-exposed patients at baseline.

Secondary objective: To compare the proportion of patients who worsen DR between V1 (inclusion) and V2 (after 3-yr of treatment) in patients exposed to incretin-based therapy from baseline vs non-exposed patients: patients with no DR or mild to moderate non proliferative DR at V1 who progress to severe DR at V2.

To evaluate whether the concentrations of angiogenic/inflammatory molecules and circulating endothelial and inflammatory cells are associated with severe DR in relation with the use of GLP-1 based therapy at V1 and V2.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 7200
• Est. completion date: April 11, 2025
• Est. primary completion date: April 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• T2D patients according to ADA criteria treated with any kind of hypoglycaemic treatment

• Age above 18 years

Exclusion Criteria:

• Type 1 diabetes

• Patients with cataract preventing DR grading

• Patients who had panretinal photocoagulation more than 10 years ago

• Documented pregnancy or lactation

Related Conditions & MeSH terms

• Retinal Diseases
• Type 2 Diabetes

Intervention

Other:
• 1: incretin-based therapy

• 2: other antidiabetic

Locations

Country	Name	City	State
France	Hôpital de la Conception	Marseille
France	Département de Diabétologie - Hopital Lariboisière	Paris

Sponsors (9)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Aix Marseille Université, Assistance Publique Hopitaux De Marseille, Centre National de la Recherche Scientifique, France, Collège de France, Institut National de la Santé Et de la Recherche Médicale, France, Pierre and Marie Curie University, University of Paris 5 - Rene Descartes, University Paris 7 - Denis Diderot

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of Severe DR at V1 (inclusion)	Retinography	at inclusion
Secondary	Prevalence of severe DR at V2 (after 3 years of treatment)	Retinography	after 3 years
Secondary	Plasma concentrations of ANGPT4		at inclusion and 3 years
Secondary	Plasma concentrations of VEGF		at inclusion and 3 years
Secondary	Plasma concentrations of proinflammatory cytokines such as IL-1beta, IL-6, IL-8, TNF-alpha		at inclusion and 3 years
Secondary	Concentrations of blood circulating EPCs and PBMCs		at inclusion and 3 years