Incretin-mimetic Hypoglycemic Drugs and Severe Retinopathy (ANGIOSAFE2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02671864|
Recruitment Status : Recruiting
First Posted : February 2, 2016
Last Update Posted : July 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Other: 1: incretin-based therapy Other: 2: other antidiabetic||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||7200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||April 11, 2016|
|Estimated Primary Completion Date :||April 11, 2022|
|Estimated Study Completion Date :||April 11, 2025|
1: incretin-based therapy
Patients with incretin-based therapy
Other: 1: incretin-based therapy
2: other antidiabetic
Patients with other antidiabetic
Other: 2: other antidiabetic
- Prevalence of Severe DR at V1 (inclusion) [ Time Frame: at inclusion ]Retinography
- Prevalence of severe DR at V2 (after 3 years of treatment) [ Time Frame: after 3 years ]Retinography
- Plasma concentrations of ANGPT4 [ Time Frame: at inclusion and 3 years ]
- Plasma concentrations of VEGF [ Time Frame: at inclusion and 3 years ]
- Plasma concentrations of proinflammatory cytokines such as IL-1beta, IL-6, IL-8, TNF-alpha [ Time Frame: at inclusion and 3 years ]
- Concentrations of blood circulating EPCs and PBMCs [ Time Frame: at inclusion and 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671864
|Contact: GAUTIER Jean-François, MD, PhD||33 1 49 95 90 firstname.lastname@example.org|
|Contact: DUTOUR Anne, MD, PhD||33 4 91 38 29 email@example.com|
|Hôpital de la Conception||Recruiting|
|Marseille, France, 13005|
|Contact: Anne DUTOUR, MD, PhD 33 4 91 38 29 63 firstname.lastname@example.org|
|Contact: Bénédicte GABORIT, MD, PhD 33 491383650 email@example.com|
|Département de Diabétologie - Hopital Lariboisière||Not yet recruiting|
|Paris, France, 75010|
|Contact: GAUTIER Jean-François, MD, PhD 33 1 49 95 90 20 firstname.lastname@example.org|
|Principal Investigator:||GAUTIER Jean-François, MD, PhD||Assistance Publique - Hôpitaux de Paris|