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

NCT ID: NCT06600555

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-03
• Study Completion Date: 2032-12-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

metabolic surgery with SLEEVE technique

Group Type: EXPERIMENTAL

metabolic surgery with SLEEVE technique

Intervention Type: PROCEDURE

metabolic surgery with SLEEVE technique

metabolic surgery with BY-PASS technique

Group Type: EXPERIMENTAL

metabolic surgery with BY-PASS technique

Intervention Type: PROCEDURE

metabolic surgery with BY-PASS technique

Interventions

metabolic surgery with SLEEVE technique

metabolic surgery with SLEEVE technique

Intervention Type: PROCEDURE

metabolic surgery with BY-PASS technique

metabolic surgery with BY-PASS technique

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Médipôle Lyon-Villeurbanne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medipole Lyon Villeurbanne

Villeurbanne, , France

Site Status: RECRUITING

Countries

France

Central Contacts

laetitia paradisi, Dr

Role: CONTACT

l.paradisi-prieur@resamut.fr

0033481655296

Facility Contacts

laetitia paradisi

Role: primary

0033481655296

Other Identifiers

CHANGE metabolic surgery

Identifier Type: -

Identifier Source: org_study_id