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

NCT06600555 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-09-19

No results posted yet for this study

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

Interventions

PROCEDURE

metabolic surgery with SLEEVE technique

metabolic surgery with SLEEVE technique

PROCEDURE

metabolic surgery with BY-PASS technique

metabolic surgery with BY-PASS technique

Sponsors & Collaborators

  • Médipôle Lyon-Villeurbanne

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-03
Primary Completion
2032-12-01
Completion
2032-12-01

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06600555 on ClinicalTrials.gov