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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• adult patient and ≤ 65 years old

• T2D patient, with individualized glycemic objectives not achieved, despite medical care, in particular diabetological and nutritional, also including adapted physical activity, well conducted according to current good practice recommendations, for at least twelve months

• BMI between 30 and 34.9 kg/m²

• patient well informed beforehand about metabolic surgery and the study

• multidisciplinary evaluation (including a diabetologist) and decision on medical treatment by CM (date prior to inclusion)

• medical assessment of an acceptable surgical risk

• patient affiliated to or beneficiary of a social security system

• patient having freely signed the written informed consent

Locations
Other Locations
France
Medipole Lyon Villeurbanne
RECRUITING
Villeurbanne
Contact Information
Primary
laetitia paradisi, Dr
l.paradisi-prieur@resamut.fr
0033481655296
Time Frame
Start Date: 2024-07-03
Estimated Completion Date: 2032-12-01
Participants
Target number of participants: 30
Treatments
Experimental: metabolic surgery with SLEEVE technique
Experimental: metabolic surgery with BY-PASS technique
Sponsors
Leads: Médipôle Lyon-Villeurbanne

This content was sourced from clinicaltrials.gov