Biological atlas and tissue collection for severe obesity
Influence of the Glycemic and Ponderal Status on Tissues Gene Expression (Biological Tissue Collection)
This project will collect blood and tissue samples from adults having abdominal surgery to test how obesity and diabetes change gene activity in tissues that control glucose and fat.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20000 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 1 site (Lille, Nord) |
| Trial ID | NCT01129297 on ClinicalTrials.gov |
What this trial studies
This prospective cohort collects blood and surgical tissue samples from adults undergoing abdominal operations to study gene expression in tissues involved in glucose and lipid metabolism. Participants are placed into four phenotype groups by BMI and glucose tolerance (severe obesity with diabetes, severe obesity with glucose intolerance, severe obesity without diabetes, and normal-weight controls). The project uses whole-genome linkage, transcriptomics, and bioinformatics and compares human findings with relevant animal models to map genetic variants and affected pathways. Samples and linked clinical data will create a biological atlas of “diabesity” to support mechanistic and therapeutic research.
Who should consider this trial
Good fit: Adults aged 18–65 who are undergoing abdominal surgery (for example bariatric surgery, cholecystectomy, or parietal repair) and meet one of the four BMI/glucose-tolerance phenotype categories are ideal candidates.
Not a fit: People who are not having abdominal surgery or who fall outside the age, BMI, or glucose-tolerance criteria are unlikely to be eligible or to receive direct benefit from participating.
Why it matters
Potential benefit: If successful, the work could reveal gene-expression patterns and pathways that point to better-targeted treatments or prevention strategies for people with obesity-related diabetes.
How similar studies have performed: Other tissue biobanks and transcriptomic studies have previously identified gene-expression signatures linked to obesity and type 2 diabetes, so the general approach has produced useful insights though this integrated genomics-to-pathway atlas is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18 and 65 years * Indication of abdominal surgery requiring a laparotomy or laparoscopy for bariatric surgery, cholecystectomy, or parietal surgical * Phenotype corresponding to one of the following four cases : 1. Body Mass Index ≥ 35 kg/m2 and diabetes defined by a fasting blood glucose ≥ 7 mmol/l and/or ≥ to 11.1 mmol/l, 120 minutes after ingestion of glucose (hyperglycemia caused by oral route) 2. Body Mass Index ≥ 35 kg/m2 with intolerance glucose defined by a fasting blood glucose\> 6 mmol/L and \<7 mmol/l and/or\> 7.8 mmol/l and \<11.1 mmol/l , 120 minutes after ingestion of glucose (hyperglycemia caused by oral route) 3. Body Mass Index ≥ 35 kg/m2 without diabetes defined by a blood glucose ≤ 6 mmol/L and / or ≤ 7.8 mmol/l, 120 minutes after ingestion of glucose (hyperglycemia caused by oral route) 4. Body Mass Index \<27 kg/m2 without diabetes defined by a blood glucose ≤ 6 mmol/L and / or ≤ 7.8 mmol/l, 120 minutes after ingestion of glucose (hyperglycemia caused by oral route) 5)27 \<Body Mass Index \<35 kg/m2 without diabetes defined by a blood glucose ≤ 6 mmol/L and / or ≤ 7.8 mmol/l, 120 minutes after ingestion of glucose (hyperglycemia caused by oral route) Exclusion Criteria: * unable to receive clear information * refusal to sign the consent form * pathology associated judged by the surgeon, may increase the risk of adverse events related to sampling tissue
Where this trial is running
Lille, Nord
- Lille University Hospital — Lille, Nord, France (Recruiting)
Study contacts
- Principal investigator: Francois PATTOU, MD PhD — University Hospital, Lille
- Study coordinator: Francois PATTOU, MD PhD
- Email: fpattou@univ-lille2.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.