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Incretin-mimetic Hypoglycemic Drugs and Severe Retinopathy (ANGIOSAFE 2)

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ClinicalTrials.gov Identifier: NCT02671864
Recruitment Status : Recruiting
First Posted : February 2, 2016
Last Update Posted : March 10, 2020
Sponsor:
Collaborators:
Assistance Publique Hopitaux De Marseille
Institut National de la Santé Et de la Recherche Médicale, France
Centre National de la Recherche Scientifique, France
Collège de France
University of Paris 5 - Rene Descartes
Pierre and Marie Curie University
University Paris 7 - Denis Diderot
Aix Marseille Université
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Other: 1: incretin-based therapy Other: 2: other antidiabetic Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Prevalence of Severe DR at V1 (inclusion) [ Time Frame: at inclusion ]

Secondary Outcome Measures :
  1. Prevalence of severe DR at V2 (after 3 years of treatment) [ Time Frame: after 3 years ]
  2. Plasma concentrations of ANGPT4 [ Time Frame: at inclusion and 3 years ]
  3. Plasma concentrations of VEGF [ Time Frame: at inclusion and 3 years ]
  4. Plasma concentrations of proinflammatory cytokines such as IL-1beta, IL-6, IL-8, TNF-alpha [ Time Frame: at inclusion and 3 years ]
  5. Concentrations of blood circulating EPCs and PBMCs [ Time Frame: at inclusion and 3 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: GAUTIER Jean-François, MD, PhD 33 1 49 95 90 20 jean-francois.gautier@aphp.fr
Contact: DUTOUR Anne, MD, PhD 33 4 91 38 29 63 anne.dutour@ap-hm.fr

Locations
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France
Hôpital de la Conception Recruiting
Marseille, France, 13005
Contact: Anne DUTOUR, MD, PhD    33 4 91 38 29 63    anne.dutour@ap-hm.fr   
Contact: Bénédicte GABORIT, MD, PhD    33 491383650    benedicte.gaborit@ap-hm.fr   
Département de Diabétologie - Hopital Lariboisière Not yet recruiting
Paris, France, 75010
Contact: GAUTIER Jean-François, MD, PhD    33 1 49 95 90 20    jean-francois.gautier@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Assistance Publique Hopitaux De Marseille
Institut National de la Santé Et de la Recherche Médicale, France
Centre National de la Recherche Scientifique, France
Collège de France
University of Paris 5 - Rene Descartes
Pierre and Marie Curie University
University Paris 7 - Denis Diderot
Aix Marseille Université
Investigators
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Principal Investigator: GAUTIER Jean-François, MD, PhD Assistance Publique - Hôpitaux de Paris
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02671864    
Other Study ID Numbers: P150601
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Incretin-based therapy
GLP1
Angiogenesis Inflammation
Hypoglycaemic treatment
Additional relevant MeSH terms:
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Retinal Diseases
Eye Diseases
Hypoglycemic Agents
Incretins
 Physiological Effects of Drugs
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists