NCT02671864

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
7,200

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable type-2-diabetes

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 2, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

April 11, 2016

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2022

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2025

Completed
Last Updated

March 6, 2023

Status Verified

March 1, 2023

Enrollment Period

6 years

First QC Date

January 29, 2016

Last Update Submit

March 2, 2023

Conditions

Type 2 Diabetes

Keywords

Incretin-based therapyGLP1Angiogenesis InflammationHypoglycaemic treatment

Outcome Measures

Primary Outcomes (1)

  • Prevalence of Severe DR at V1 (inclusion)

    Retinography

    at inclusion

Secondary Outcomes (5)

  • Prevalence of severe DR at V2 (after 3 years of treatment)

    after 3 years

  • Plasma concentrations of ANGPT4

    at inclusion and 3 years

  • Plasma concentrations of VEGF

    at inclusion and 3 years

  • Plasma concentrations of proinflammatory cytokines such as IL-1beta, IL-6, IL-8, TNF-alpha

    at inclusion and 3 years

  • Concentrations of blood circulating EPCs and PBMCs

    at inclusion and 3 years

Study Arms (2)

1: incretin-based therapy

OTHER

Patients with incretin-based therapy

Other: 1: incretin-based therapy

2: other antidiabetic

OTHER

Patients with other antidiabetic

Other: 2: other antidiabetic

Interventions

1: incretin-based therapyOTHER
1: incretin-based therapy
2: other antidiabeticOTHER
2: other antidiabetic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • T2D patients according to ADA criteria treated with any kind of hypoglycaemic treatment
  • Age above 18 years

You may not qualify if:

  • Type 1 diabetes
  • Patients with cataract preventing DR grading
  • Patients who had panretinal photocoagulation more than 10 years ago
  • Documented pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital de la Conception

Marseille, 13005, France

Location

Département de Diabétologie - Hopital Lariboisière

Paris, 75010, France

Location

Related Publications (1)

  • 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.

    PMID: 31589290DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • GAUTIER Jean-François, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2016

First Posted

February 2, 2016

Study Start

April 11, 2016

Primary Completion

April 11, 2022

Study Completion

April 11, 2025

Last Updated

March 6, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)