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

NCT06600555 | Recruiting

• 1 other identifier: CHANGE metabolic surgery
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• T2DM remission rate

  HbA1c lower than 6.5% in the absence of antidiabetic treatment, partial, complete, prolonged remission or no remission between the 2 surgical techniques

  1 year after surgery

Study Arms (2)

metabolic surgery with SLEEVE technique

EXPERIMENTAL

Procedure: metabolic surgery with SLEEVE technique

metabolic surgery with BY-PASS technique

EXPERIMENTAL

Procedure: metabolic surgery with BY-PASS technique

Interventions

metabolic surgery with SLEEVE technique PROCEDURE

metabolic surgery with SLEEVE technique

metabolic surgery with SLEEVE technique

metabolic surgery with BY-PASS technique PROCEDURE

metabolic surgery with BY-PASS technique

metabolic surgery with BY-PASS technique

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Médipôle Lyon-Villeurbanne: lead

Study Sites (1)

Medipole Lyon Villeurbanne

Villeurbanne, 69100, France

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Central Study Contacts

laetitia paradisi, Dr

CONTACT

0033481655296; l.paradisi-prieur@resamut.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start: July 3, 2024
• Primary Completion (Estimated): December 1, 2032
• Study Completion (Estimated): December 1, 2032
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)