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Age: 18Years - 70Years
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ID04581447

Randomized Trial Studying Metformin Addition to Standard Care to Extend Diabetes Remission After Bariatric Surgery in Adults

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

126

Participants Needed

16

Research Sites

17 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating whether adding metformin to standard care can extend the time people stay in diabetes remission after bariatric surgery. This study focuses on adults who had gastric bypass or sleeve gastrectomy surgery and previously had type 2 diabetes. The trial is randomized, controlled, open-label, and involves multiple centers to compare the effects of metformin addition on diabetes remission duration over three years. Participants are assigned to one of two groups one group receives standard care plus metformin, starting at 850 mg once daily and increasing to twice daily after one month, while the other group receives standard care alone. Both groups receive regular lifestyle recommendations from nutrition and physical activity experts every six months. A subgroup of patients in the metformin group will undergo additional testing to study how metformin affects gut hormones. During the three-year study, participants will have follow-up visits every six months to monitor diabetes status, body weight, metabolic health, and quality of life. If diabetes returns, treatment with metformin or standard care stops, but participants remain in the study for further evaluation. Researchers will track a wide range of health measures including blood tests, diabetes remission status, nutritional status, medication adherence, and side effects to understand metformins impact after bariatric surgery.

CONDITIONS

Brief Title

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

Research Team

A

Aurélie GUIMFACK

Y

Yvann FRIGOUT

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