Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02861781
Recruitment Status : Recruiting
First Posted : August 10, 2016
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Obesity Insulin Resistance Diabetes Mellitus, Type 2 Other: Collection of blood samples and tissues

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 270 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of New Determinants of Type 2 Diabetes in Severe Obesity
Actual Study Start Date : February 2, 2016
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subject qualified for bariatric surgery
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02861781


Contacts
Layout table for location contacts
Contact: Florence Galtier, MD f-galtier@chu-montpellier.fr

Locations
Layout table for location information
France
Hôpital Saint Eloi Recruiting
Montpellier, France, 34295
Contact: Florence Galtier, MD       f-galtier@chu-montpellier.fr   
Principal Investigator: Florence Galtier, MD         
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Layout table for investigator information
Principal Investigator: Florence GALTIER Montpellier University Hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: 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 )
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Keywords provided by University Hospital, Montpellier:
Bariatric surgery
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Diabetes Mellitus, Type 2
Insulin Resistance
Overnutrition
Nutrition Disorders
Overweight
 Body Weight
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism