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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Diabetes Mellitus, Type 2
• Intervention / Treatment: Procedure: metabolic surgery with SLEEVE technique; Procedure: metabolic surgery with BY-PASS technique

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: laetitia paradisi, Dr; Phone Number: 0033481655296; Email: l.paradisi-prieur@resamut.fr

Study Locations

• France
  • Villeurbanne, France, 69100
    • Recruiting
    • Médipole Lyon Villeurbanne
    • Contact: laetitia paradisi; Phone Number: 0033481655296

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: metabolic surgery with SLEEVE technique	Procedure: metabolic surgery with SLEEVE technique; metabolic surgery with SLEEVE technique
Experimental: metabolic surgery with BY-PASS technique	Procedure: metabolic surgery with BY-PASS technique; metabolic surgery with BY-PASS technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Médipôle Lyon-Villeurbanne

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2024
• Primary Completion (Estimated): December 1, 2032
• Study Completion (Estimated): December 1, 2032

Study Registration Dates

• First Submitted: September 9, 2024
• First Submitted That Met QC Criteria: September 12, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 12, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: CHANGE metabolic surgery

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No