Collection of Human Metabolic Tissues

Launched by UNIVERSITY HOSPITAL, MONTPELLIER · Aug 5, 2016

Keywords

ClinConnect Summary

This clinical trial is focused on understanding the causes of type 2 diabetes in people with severe obesity. Researchers plan to collect different types of metabolic tissues from patients undergoing bariatric surgery, which is a procedure to help with weight loss. They will look at three groups of patients based on their metabolic health: those with type 2 diabetes, those with insulin resistance (a condition where the body does not use insulin well), and those with insulin sensitivity (where the body uses insulin effectively). By comparing these groups, the study aims to identify biological processes that contribute to type 2 diabetes and other obesity-related issues.

To participate, you must be between 18 and 65 years old, have a body mass index (BMI) over 35, and qualify for bariatric surgery (like gastric sleeve or bypass). The researchers will gather information at the time of surgery and then follow up with patients 3 and 12 months later to see how their metabolism changes. It's important to know that if you have certain health conditions or have had previous bariatric surgery (except for a specific type), you may not be eligible. If you join the study, you’ll be contributing to valuable research that could help improve understanding and treatment of obesity and diabetes in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Written informed consent
• • 2. Age 18 - 65 years inclusive at surgery
• • 3. IMC \> 35
• • 4. Subject qualified for bariatric surgery (sleeve gastrectomy or gastric bypass)
• 5. Specific criteria :
• • Type 2 diabetes group (D) (90 patients) : type 2 diabetes according to ADA criteria
• • Insulin resistance non diabetes group (IR) (80 patients) : HOMA-IR criteria ≥ 3
• • Insulin Sensitivity non diabetes group (N) (100 patients) : N1.HOMA-IR criteria \< 3
• Non inclusion Criteria:
• • 1. Vulnerability according to article L1121-6 of the Public Health Code
• • 2. Protected adult or unability to give consent according to article L1121-8 of the Public Health Code
• • 3. Unability to understand the design and aims of the study or to communicate with the investigator
• • 4. Non affiliation to a social security system
• • 5. Prior bariatric surgery (except lap-band procedure)
• • 6. Serologic profile indicating hepatitis B, hepatitis C or HIV infection
• • 7. Inflammatory, infectious or autoimmune disease (current or in the previous 3 month)
• • 8. Malignancies within 5 years prior to inclusion or not considered as treated curatively
• • 9. Concomitant use of steroids or NSAI or use in the 8 days before surgery
• • 10. alcohol abuse/addiction
• • 11. Anticipated poor compliance to study procedures
• • 12. Other type of diabetes than type 2
• Exclusion Criteria :
• • 1. Cancelled bariatric surgery
• • 2. Tissue collection not possible during the bariatric surgery