Collection of Human Metabolic Tissues (COMET)

May 2, 2023 updated by: University Hospital, Montpellier

Study of New Determinants of Type 2 Diabetes in Severe Obesity

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

270

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Recruiting
        • Hopital Saint Eloi
        • Principal Investigator:
          • Florence GALTIER, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Subject qualified for bariatric surgery

Description

Inclusion Criteria:

  1. Written informed consent
  2. Age 18 - 65 years inclusive at surgery
  3. IMC > 35
  4. Subject qualified for bariatric surgery (sleeve gastrectomy or gastric bypass)

  5. 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:

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

Exclusion Criteria :

  1. Cancelled bariatric surgery
  2. Tissue collection not possible during the bariatric surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Type 2 diabetes
Type 2 diabetes according to ADA criteria
Other: Collection of blood samples and tissues
Collection of blood samples and tissues during bariatric surgery and blood samples during followup visits
Insulin resistance non diabetes
HOMA-IR criteria ≥ 3
Other: Collection of blood samples and tissues
Collection of blood samples and tissues during bariatric surgery and blood samples during followup visits
Insulin sensitivity non diabetes
HOMA-IR criteria < 3
Other: Collection of blood samples and tissues
Collection of blood samples and tissues during bariatric surgery and blood samples during followup visits

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparison of metabolites
Time Frame: At baseline (day of surgery)
At baseline (day of surgery)
comparison of proteins levels
Time Frame: At baseline (day of surgery)
in liver, muscle, adipose tissue and plasma according to metabolic state
At baseline (day of surgery)
comparison of miRNA
Time Frame: At baseline (day of surgery)
in liver, muscle, adipose tissue and plasma according to metabolic state
At baseline (day of surgery)

Secondary Outcome Measures

Outcome Measure
Time Frame
changes in metabolites in plasma level
Time Frame: 3 and 12 months after the completion of surgery
3 and 12 months after the completion of surgery
changes in proteins in plasma level
Time Frame: 3 and 12 months after the completion of surgery
3 and 12 months after the completion of surgery
changes in miRNA in plasma level
Time Frame: 3 and 12 months after the completion of surgery
3 and 12 months after the completion of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: Florence GALTIER, Montpellier University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2016

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

September 1, 2024

Study Registration Dates

First Submitted

August 2, 2016

First Submitted That Met QC Criteria

August 5, 2016

First Posted (Estimate)

August 10, 2016

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

May 2, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL15_0271
  • 2015-A01193-46 (Other Identifier: French Agency for the Safety of Health Products)
  • UF 9605 (Other Identifier: Montpellier University Hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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