We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02861781
Previous Study | Return to List | Next Study

Collection of Human Metabolic Tissues (COMET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02861781
Recruitment Status : Unknown
Verified January 2020 by University Hospital, Montpellier.
Recruitment status was:  Recruiting
First Posted : August 10, 2016
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Tracking Information
First Submitted Date August 2, 2016
First Posted Date August 10, 2016
Last Update Posted Date January 9, 2020
Actual Study Start Date February 2, 2016
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 5, 2016)
  • comparison of metabolites [ Time Frame: 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
  • comparison of miRNA [ Time Frame: At baseline (day of surgery) ]
    in liver, muscle, adipose tissue and plasma according to metabolic state
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 5, 2016)
  • changes in metabolites in plasma level [ Time Frame: 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 ]
  • changes in miRNA in plasma level [ Time Frame: 3 and 12 months after the completion of surgery ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Collection of Human Metabolic Tissues
Official Title Study of New Determinants of Type 2 Diabetes in Severe Obesity
Brief 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Subject qualified for bariatric surgery
Condition
  • Obesity
  • Insulin Resistance
  • Diabetes Mellitus, Type 2
Intervention Other: Collection of blood samples and tissues
Collection of blood samples and tissues during bariatric surgery and blood samples during followup visits
Study Groups/Cohorts
  • Type 2 diabetes
    Type 2 diabetes according to ADA criteria
    Intervention: Other: Collection of blood samples and tissues
  • Insulin resistance non diabetes
    HOMA-IR criteria ≥ 3
    Intervention: Other: Collection of blood samples and tissues
  • Insulin sensitivity non diabetes
    HOMA-IR criteria < 3
    Intervention: Other: Collection of blood samples and tissues
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: August 5, 2016)
270
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2022
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02861781
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 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party University Hospital, Montpellier
Original Responsible Party Same as current
Current Study Sponsor University Hospital, Montpellier
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Florence GALTIER Montpellier University Hospital
PRS Account University Hospital, Montpellier
Verification Date January 2020