Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06600555
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
Evaluation of the Metabolic Surgery Technique for Glycemic Improvement in Type 2 Diabetes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
CHANGE Evaluation of the Metabolic Surgery Technique for Glycemic Improvement in Type 2 Diabetes
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHANGE
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None