Incretin-mimetic Hypoglycemic Drugs and Severe Retinopathy

NCT ID: NCT02671864

Last Updated: 2023-03-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 7200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-11
• Study Completion Date: 2025-04-11

Brief 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.

Detailed 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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

1: incretin-based therapy

Patients with incretin-based therapy

Group Type: OTHER

1: incretin-based therapy

Intervention Type: OTHER

2: other antidiabetic

Patients with other antidiabetic

Group Type: OTHER

2: other antidiabetic

Intervention Type: OTHER

Interventions

1: incretin-based therapy

Intervention Type: OTHER

2: other antidiabetic

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

Centre National de la Recherche Scientifique, France

OTHER

Sponsor Role: collaborator

Collège de France

UNKNOWN

Sponsor Role: collaborator

University of Paris 5 - Rene Descartes

OTHER

Sponsor Role: collaborator

Pierre and Marie Curie University

OTHER

Sponsor Role: collaborator

University Paris 7 - Denis Diderot

OTHER

Sponsor Role: collaborator

Aix Marseille Université

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GAUTIER Jean-François, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital de la Conception

Marseille, , France

Département de Diabétologie - Hopital Lariboisière

Paris, , France

Countries

France

References

Gaborit B, Julla JB, Besbes S, Proust M, Vincentelli C, Alos B, Ancel P, Alzaid F, Garcia R, Mailly P, Sabatier F, Righini M, Gascon P, Matonti F, Houssays M, Goumidi L, Vignaud L, Guillonneau X, Erginay A, Dupas B, Marie-Louise J, Autie M, Vidal-Trecan T, Riveline JP, Venteclef N, Massin P, Muller L, Dutour A, Gautier JF, Germain S. Glucagon-like Peptide 1 Receptor Agonists, Diabetic Retinopathy and Angiogenesis: The AngioSafe Type 2 Diabetes Study. J Clin Endocrinol Metab. 2020 Apr 1;105(4):dgz069. doi: 10.1210/clinem/dgz069.

Reference Type: DERIVED

PMID: 31589290 (View on PubMed)

Other Identifiers

P150601

Identifier Type: -

Identifier Source: org_study_id