Actively Recruiting

Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID01129297

Influence of the Glycemic and Ponderal Status on Tissues Gene Expression Biological Tissue Collection for Obesity and Diabetes

Led by University Hospital, Lille · Updated on 2025-12-08

20000

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the relationship between obesity and type 2 diabetes, conditions influenced by both genetic and environmental factors. This study aims to better understand how different genetic variations affect gene expression in tissues involved in glucose and lipid metabolism, which may contribute to what is called "diabesity," a combined condition of diabetes and obesity. The study uses advanced genomic techniques and bioinformatics to analyze these factors in both humans and animal models. Participants in this observational study are grouped based on their body mass index (BMI) and diabetes or glucose intolerance status. Groups include individuals with BMI ≥ 35 kg/m2 with diabetes, glucose intolerance, or without diabetes, as well as those with BMI < 27 kg/m2 and BMI between 27 and 35 kg/m2 without diabetes. Samples are collected during abdominal surgeries such as bariatric surgery or cholecystectomy to study gene expression and metabolic pathways. During the study, researchers collect biological samples at baseline and follow participants over several years to assess changes in gene expression and insulin resistance. They also evaluate clinical and biological features before and after bariatric surgery at 1, 2, and 5 years. The primary measurement focuses on gene expression in tissues related to glucose metabolism. This long-term observation helps to understand the genetic and phenotypic factors influencing obesity and diabetes, with participation lasting up to 5 years.

CONDITIONS

Brief Title

A Biological Atlas of Severe Obesity (Biological Tissue Collection)

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 65 years
  • Scheduled for abdominal surgery requiring laparotomy or laparoscopy such as bariatric surgery, gallbladder removal, or abdominal wall surgery
  • Body Mass Index (BMI) ≥ 35 kg/m2 with diabetes (fasting blood glucose ≥ 7 mmol/l and/or ≥ 11.1 mmol/l after 120 minutes of glucose ingestion)
  • Body Mass Index (BMI) ≥ 35 kg/m2 with glucose intolerance (fasting blood glucose > 6 mmol/L and < 7 mmol/l and/or > 7.8 mmol/l and < 11.1 mmol/l after 120 minutes of glucose ingestion)
  • Body Mass Index (BMI) ≥ 35 kg/m2 without diabetes (blood glucose ≤ 6 mmol/L and/or ≤ 7.8 mmol/l after 120 minutes of glucose ingestion)
  • Body Mass Index (BMI) < 27 kg/m2 without diabetes (blood glucose ≤ 6 mmol/L and/or ≤ 7.8 mmol/l after 120 minutes of glucose ingestion)
  • Body Mass Index (BMI) between 27 and 35 kg/m2 without diabetes (blood glucose ≤ 6 mmol/L and/or ≤ 7.8 mmol/l after 120 minutes of glucose ingestion)
Not Eligible

You will not qualify if you...

  • Unable to receive clear information about the study
  • Refusal to sign the consent form
  • Any pathology judged by the surgeon to increase risk of adverse events related to tissue sampling

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Day of surgery and immediate recovery period

Participants undergo abdominal surgery such as bariatric surgery, gallbladder removal, or abdominal wall surgery during which biological tissue samples are collected.

1 surgical visit (in-person)

Long-term Monitoring

Duration - Up to 5 years

Participants are followed prospectively to assess clinical and biological features related to obesity and diabetes, including gene expression and insulin resistance indices.

Follow-up visits at 1 year, 2 years, and 5 years (in-person)

Trial Site Locations

Total: 1 location

1

Lille University Hospital

Lille, Nord, France

Actively Recruiting

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Research Team

F

Francois PATTOU, MD PhD

V

Violeta Raverdy, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

5

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Published Research Related To This Trial

Combining diabetes, sex, and menopause as meaningful clinical features associated with NASH and liver fibrosis in individuals with class II and III obesity: A retrospective cohort study.

Violeta Raverdy, Estelle Chatelain, Guillaume Lasailly...

https://pubmed.ncbi.nlm.nih.gov/37987186

Development and validation of an interpretable machine learning-based calculator for predicting 5-year weight trajectories after bariatric surgery: a multinational retrospective cohort SOPHIA study.

Patrick Saux, Pierre Bauvin, Violeta Raverdy...

https://pubmed.ncbi.nlm.nih.gov/37652841

Hepatic transcriptomic signatures of statin treatment are associated with impaired glucose homeostasis in severely obese patients.

Daniel Margerie, Philippe Lefebvre, Violeta Raverdy...

https://pubmed.ncbi.nlm.nih.gov/31159817