Evaluation of the Metabolic Surgery Technique for Glycemic Improvement in Type 2 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMédipôle Lyon-Villeurbanne
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
metabolic surgery with SLEEVE technique
Procedure/Surgerymetabolic surgery with SLEEVE technique
metabolic surgery with BY-PASS technique
Procedure/Surgerymetabolic surgery with BY-PASS technique
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: metabolic surgery with SLEEVE techniqueExperimental treatment 1 intervention
Group B: metabolic surgery with BY-PASS techniqueExperimental treatment 1 intervention
Trial outcomes
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
Time frame
1 year after surgerySponsors and contacts
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Source ClinicalTrials.gov