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

Launched by MÉDIPÔLE LYON-VILLEURBANNE · Sep 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of different types of surgery on improving blood sugar levels in adults with type 2 diabetes who are also dealing with moderate obesity. While surgery for weight loss has been common, this trial focuses on a special kind of surgery called metabolic surgery, which aims to help manage diabetes rather than just reduce weight. Participants might undergo one of several surgical techniques, such as sleeve surgery or bypass surgery. The goal of the trial is to find out which technique works best for improving diabetes and is the safest for patients.

To be eligible for this study, participants must be adults aged 65 or younger who have been struggling to manage their diabetes despite trying medical treatments and lifestyle changes for at least a year. They should also have a body mass index (BMI) between 30 and 34.9, meaning they are moderately overweight. Before joining, participants will receive detailed information about the surgery and the trial, and they must agree to be part of it by signing a consent form. If accepted into the study, participants can expect close medical monitoring and follow-up to better understand the outcomes of the surgery they receive.

Gender

ALL

Eligibility criteria

• 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