Biological atlas and tissue collection for severe obesity

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 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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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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.