Collection of human metabolic tissues from obese patients undergoing bariatric surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project aims to identify new determinants of type 2 diabetes in individuals with severe obesity by collecting biological samples during bariatric surgery. The study will categorize patients into three groups based on their metabolic status: those with type 2 diabetes, insulin resistance, and insulin sensitivity. Researchers will analyze various biological processes, including transcriptome, proteome, and metabolome abnormalities, as well as immune responses and genetic polymorphisms, to better understand the pathophysiology of type 2 diabetes and obesity-related disorders.

Why it matters

Who can join: the full rules

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

Where it's running

• Hôpital Saint Eloi
  Montpellier, France Recruiting

Study contacts

• Principal investigator: Florence GALTIER — University Hospital, Montpellier
• Study coordinator: Florence Galtier, MD
• Email: f-galtier@chu-montpellier.fr

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.