Actively Recruiting

Age: 18Years - 65Years
All Genders
NCT02861781

Collection of Human Metabolic Tissues

Led by University Hospital, Montpellier · Updated on 2026-05-08

270

Participants Needed

1

Research Sites

656 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This project aims at identifying new determinants of type 2 diabetes in severe obesity. To do so, a biological collection, including tissues of interest in the field of metabolism, will be collected during bariatric surgery in obese patients. Three different groups of metabolic status of patients, corresponding to different stages of evolution of the disease, will be constituted: type 2 diabetes, insulin resistance, insulin sensitivity. The main objective is to compare, between these 3 groups of patients, several biological processes that may be involved in the pathophysiology of type 2 diabetes and disorders associated with obesity, including: * Abnormalities of the transcriptome, proteome, metabolome in all target tissues (plasma, serum, muscle, subcutaneous and visceral adipose tissue, omental artery, liver) * Identification of metabolic signatures, protein and miRNA in plasma * Immunoinflammatory response in adipose tissue * Polymorphisms SNP from whole blood * Histological analysis of tissue sections This main objective will be studied on samples taken at the time of surgery Secondary objectives will be to study the changes in metabolites, proteins and miRNA in plasma level 3 and 12 months after the completion of surgery, according to the initial metabolic state.

CONDITIONS

Official Title

Collection of Human Metabolic Tissues

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Written informed consent
  • Age 18 to 65 years inclusive at surgery
  • Body mass index (BMI) greater than 35
  • Qualified for bariatric surgery (sleeve gastrectomy or gastric bypass)
  • For type 2 diabetes group: diagnosed with type 2 diabetes according to ADA criteria
  • For insulin resistance non-diabetes group: HOMA-IR criteria ≥ 3
  • For insulin sensitivity non-diabetes group: HOMA-IR criteria < 3
Not Eligible

You will not qualify if you...

  • Vulnerability according to article L1121-6 of the Public Health Code
  • Protected adult or unable to give consent according to article L1121-8 of the Public Health Code
  • Unable to understand the study design or communicate with the investigator
  • Not affiliated with a social security system
  • Prior bariatric surgery except lap-band procedure
  • Positive serologic tests for hepatitis B, hepatitis C, or HIV infection
  • Current or recent (within 3 months) inflammatory, infectious, or autoimmune disease
  • Malignancies within 5 years prior to inclusion or not treated curatively
  • Use of steroids or NSAIDs in the 8 days before surgery
  • Alcohol abuse or addiction
  • Anticipated poor compliance with study procedures
  • Diabetes type other than type 2
  • Cancelled bariatric surgery
  • Tissue collection not possible during bariatric surgery

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Hôpital Saint Eloi

Montpellier, France, 34295

Actively Recruiting

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Research Team

F

Florence Galtier, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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