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

Médipôle Lyon-Villeurbanne

Status

Enrolling

Conditions

Obesity

Diabetes Mellitus, Type 2

Treatments

Procedure: metabolic surgery with SLEEVE technique

Procedure: metabolic surgery with BY-PASS technique

Study type

Interventional

Funder types

Other

Identifiers

NCT06600555

CHANGE metabolic surgery

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

severe cognitive or mental disorders
severe and unstabilized eating behavior disorders
dependence on alcohol and licit and illicit psychoactive substances
illnesses endangering life in the short and medium term
contraindications to general anesthesia
absence of identified prior medical care and foreseeable inability of the patient to participate in lifelong medical monitoring
history of bariatric surgery
pregnant or breastfeeding woman, or having a very long-term pregnancy plan short term (< 2 years)
adult patient under guardianship or curatorship
patient deprived of liberty or under judicial decision