Collection of human metabolic tissues from obese patients undergoing bariatric surgery
Study of New Determinants of Type 2 Diabetes in Severe Obesity
This study is collecting tissue samples from obese patients having weight loss surgery to see how different metabolic conditions affect type 2 diabetes and obesity.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 270 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT02861781 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a BMI greater than 35 who are qualified for bariatric surgery.
Not a fit: Patients with prior bariatric surgery or those with certain infectious or autoimmune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to improved understanding and treatment strategies for type 2 diabetes and obesity.
How similar studies have performed: Other studies have shown success in identifying metabolic determinants in obesity and diabetes, making this approach promising.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Montpellier
- Hôpital Saint Eloi — Montpellier, France (Recruiting)
Study contacts
- Principal investigator: Florence GALTIER — Montpellier University Hospital
- Study coordinator: Florence Galtier, MD
- Email: f-galtier@chu-montpellier.fr
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.