Skip to main content
OpenTrials
Recruiting

NCT Number: NCT02861781

Collection of Human Metabolic Tissues

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Obesity Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Saint Eloi

Montpellier, 34295, France

Location status: Recruiting

Location contact

Florence Galtier, MD

CONTACT

[email protected]

Florence Galtier, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent
  • Age 18 - 65 years inclusive at surgery
  • IMC > 35
  • Subject qualified for bariatric surgery (sleeve gastrectomy or gastric bypass)
  • Specific criteria :
  • Type 2 diabetes group (D) (90 patients) : type 2 diabetes according to ADA criteria
  • Insulin resistance non diabetes group (IR) (80 patients) : HOMA-IR criteria ≥ 3
  • Insulin Sensitivity non diabetes group (N) (100 patients) : N1.HOMA-IR criteria < 3

Non inclusion Criteria:

  • Vulnerability according to article L1121-6 of the Public Health Code
  • Protected adult or unability to give consent according to article L1121-8 of the Public Health Code
  • Unability to understand the design and aims of the study or to communicate with the investigator
  • Non affiliation to a social security system
  • Prior bariatric surgery (except lap-band procedure)
  • Serologic profile indicating hepatitis B, hepatitis C or HIV infection
  • Inflammatory, infectious or autoimmune disease (current or in the previous 3 month)
  • Malignancies within 5 years prior to inclusion or not considered as treated curatively
  • Concomitant use of steroids or NSAI or use in the 8 days before surgery
  • alcohol abuse/addiction
  • Anticipated poor compliance to study procedures
  • Other type of diabetes than type 2

Exclusion criteria

  • Cancelled bariatric surgery
  • Tissue collection not possible during the bariatric surgery

Treatment and study plan

Collection of blood samples and tissues

Other

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

Primary outcomes

  1. comparison of metabolites

    Time frame: At baseline (day of surgery)

  2. comparison of proteins levels

    Time frame: At baseline (day of surgery)

    in liver, muscle, adipose tissue and plasma according to metabolic state

  3. comparison of miRNA

    Time frame: At baseline (day of surgery)

    in liver, muscle, adipose tissue and plasma according to metabolic state

Secondary outcomes

  1. changes in metabolites in plasma level

    Time frame: 3 and 12 months after the completion of surgery

  2. changes in proteins in plasma level

    Time frame: 3 and 12 months after the completion of surgery

  3. changes in miRNA in plasma level

    Time frame: 3 and 12 months after the completion of surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Florence Galtier, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Study of New Determinants of Type 2 Diabetes in Severe Obesity

Acronym: COMET

Important dates

Study start
2016
Primary completion
2028
Study completion
2028
First posted
Aug 10, 2016
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.