Actively Recruiting

Phase 3
Age: 18Years - 70Years
All Genders
NCT04581447

Extending Time Without Diabetes After Bariatric Surgery: a Trial Comparing the Metformin Addition or Not to Standard Care

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2023-06-08

126

Participants Needed

16

Research Sites

303 weeks

Total Duration

On this page

Sponsors

A

Assistance Publique - Hôpitaux de Paris

Lead Sponsor

M

Ministry of Health, France

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study is a randomized trial that evaluates the effect of metformin addition or not to standard care on the duration of diabetes remission after bariatric surgery.

CONDITIONS

Official Title

Extending Time Without Diabetes After Bariatric Surgery: a Trial Comparing the Metformin Addition or Not to Standard Care

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 18-70 years old
  • Had gastric bypass or sleeve gastrectomy 12 to 36 ±3 months before joining
  • Had type 2 diabetes treated with at least one anti-diabetic drug before surgery or HbA1c ≥ 6.5% before surgery
  • Have HbA1c less than 6.5% at inclusion with no diabetes medications for the last three months
  • Provided written consent
Not Eligible

You will not qualify if you...

  • Known type 1 diabetes
  • Pregnant or breastfeeding
  • Estimated kidney function (glomerular filtration rate) below 44 ml/min
  • Known intolerance or contraindications to metformin, including acute metabolic acidosis, conditions causing kidney problems, severe heart or lung diseases, recent heart attack, liver failure, very low prothrombin ratio, very high liver enzymes, or alcohol use disorder
  • Taking medications or having medical conditions that interfere with diabetes assessment such as glucocorticoid treatment, kidney transplant, Cushing's syndrome, acromegaly, or very high triglycerides despite treatment
  • Under legal protection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 16 locations

1

CHU Amiens-Picardie - hôpital Nord

Amiens, France

Actively Recruiting

2

AP-HP - hôpital Avicenne

Bobigny, France

Withdrawn

3

CHU de Bordeaux - hôpital Haut-Lévêque

Bordeaux, France

Actively Recruiting

4

AP-HP - hôpital Ambroise-Paré

Boulogne-Billancourt, France

Actively Recruiting

5

AP-HP - hôpital Louis-Mourier

Colombes, France

Actively Recruiting

6

Centre hospitalier intercommunal de Créteil

Créteil, France

Actively Recruiting

7

CHU de Lille - hôpital Claude Huriez

Lille, France

Actively Recruiting

8

AP-HM - hôpital de la Conception

Marseille, France

Actively Recruiting

9

AP-HM - hôpital Nord

Marseille, France

Withdrawn

10

AP-HP - hôpital européen Georges-Pompidou

Paris, France, 75015

Actively Recruiting

11

AP-HP - hôpital Bichat-Claude Bernard

Paris, France

Actively Recruiting

12

AP-HP - hôpital de la Pitié-Salpêtrière

Paris, France

Actively Recruiting

13

Institut Mutualiste Montsouris

Paris, France

Actively Recruiting

14

HCL - centre hospitalier Lyon-Sud

Pierre-Bénite, France

Actively Recruiting

15

CH de Saint-Denis - hôpital Delafontaire

Saint-Denis, France

Not Yet Recruiting

16

CHU de Toulouse - hôpital Larrey

Toulouse, France

Actively Recruiting

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Research Team

A

Aurélie GUIMFACK

CONTACT

Y

Yvann FRIGOUT

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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