NCT06600555

Evaluation of the Metabolic Surgery Technique for Glycemic Improvement in Type 2 Diabetes

CHANGE Evaluation of the Metabolic Surgery Technique for Glycemic Improvement in Type 2 Diabetes

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Médipôle Lyon-Villeurbanne · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Surgery is one of the management options for type 2 diabetes in patients with moderate obesity. This is a recent option because it has been part of the recommendations since October 2022. The possible surgical techniques are the same as those for bariatric surgery: * Sleeve, * Bypass, * Gastric band, but the main goal is not weight loss, it is remission of type 2 diabetes. It is called metabolic surgery. The ring technique (gastroplasty) is practiced less and less in France because it is less effective in weight loss and is responsible for major discomfort. Currently, metabolic surgery is one of the recommendations but no study has compared the effectiveness of the techniques with each other. One or other of the techniques can be chosen according to the preferences of the surgeon, the patient, the center, etc. but this choice is not made objectively, in the absence of comparative data. This study would like to follow up on patients for whom metabolic surgery has been proposed by the doctor,. If the surgery is accepted, this study would like to improve knowledge of the effectiveness of the different techniques, and thus demonstrate which metabolic surgery technique is preferred in terms of effectiveness and safety.

Conditions

• Diabetes Mellitus, Type 2
• Obesity

Interventions

Type	Name	Description
PROCEDURE	metabolic surgery with SLEEVE technique	metabolic surgery with SLEEVE technique
PROCEDURE	metabolic surgery with BY-PASS technique	metabolic surgery with BY-PASS technique

Timeline

• Start date: 2024-07-03
• Primary completion: 2032-12-01
• Completion: 2032-12-01
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: France