RecruitingNCT02861781

Collection of Human Metabolic Tissues

Study of New Determinants of Type 2 Diabetes in Severe Obesity


Sponsor

University Hospital, Montpellier

Enrollment

270 participants

Start Date

Feb 2, 2016

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting fat, muscle, and other tissue samples during weight-loss (bariatric) surgery from patients with severe obesity to study the biological differences between people with type 2 diabetes, insulin resistance, and normal insulin sensitivity, in order to better understand how the body's metabolism works. **You may be eligible if...** - You are between 18 and 65 years old - You have a body mass index (BMI) over 35, which is classified as severe obesity - You have been approved for bariatric surgery such as sleeve gastrectomy or gastric bypass - You fall into one of three groups: type 2 diabetes, insulin resistance without diabetes, or normal insulin sensitivity **You may NOT be eligible if...** - You are unable to give legal consent under French health law - You cannot understand the study's purpose or communicate with the research team - You are not enrolled in the French social security system - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERCollection of blood samples and tissues

Collection of blood samples and tissues during bariatric surgery and blood samples during followup visits


Locations(1)

Hôpital Saint Eloi

Montpellier, France

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NCT02861781


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