ObesityCOMETNCT02861781
Collection of Human Metabolic Tissues
An observational study of Obesity and Insulin Resistance, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Insulin Resistance, Diabetes Mellitus, Type 2
- What is being tested?
- Collection of blood samples and tissues
- How many people
- 270 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2016to Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subject qualified for bariatric surgery
Who may be able to join
- 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
Show all 21Show fewer
- 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
Who cannot join
- Cancelled bariatric surgery
- Tissue collection not possible during the bariatric surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Florence Galtier, MD contact
France1 site, 1 recruiting
- Recruiting
Hôpital Saint Eloi
Montpellier, 34295
Florence Galtier, MD, f-galtier@chu-montpellier.fr
Florence Galtier, MD
About this study
Official title: 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.
- Conditions
- Obesity, Insulin Resistance, Diabetes Mellitus, Type 2
- Being tested
- Collection of blood samples and tissues
- Keywords
- Bariatric surgery
- Medical subject headings
- Obesity, Insulin Resistance, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of blood samples and tissuesOther
Collection of blood samples and tissues during bariatric surgery and blood samples during followup visits
| Study group | Role | What they receive |
|---|---|---|
| Type 2 diabetes | Type 2 diabetes according to ADA criteria Receives: Other: Collection of blood samples and tissues | |
| Insulin resistance non diabetes | HOMA-IR criteria ≥ 3 Receives: Other: Collection of blood samples and tissues | |
| Insulin sensitivity non diabetes | HOMA-IR criteria < 3 Receives: Other: Collection of blood samples and tissues |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of metabolites
Measured: At baseline (day of surgery)
comparison of proteins levels
in liver, muscle, adipose tissue and plasma according to metabolic state
Measured: At baseline (day of surgery)
comparison of miRNA
in liver, muscle, adipose tissue and plasma according to metabolic state
Measured: At baseline (day of surgery)
Secondary outcomes (3)
changes in metabolites in plasma level
Measured: 3 and 12 months after the completion of surgery
changes in proteins in plasma level
Measured: 3 and 12 months after the completion of surgery
changes in miRNA in plasma level
Measured: 3 and 12 months after the completion of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study start2 Feb 2016
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence GALTIER, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02861781
- Sponsor's protocol ID
- RECHMPL15_0271
- Other IDs
- 2015-A01193-46, UF 9605
- Acronym
- COMET
- Status last verified
- May 2026
- First submitted
- 2 Aug 2016
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Riviere B, Jaussent A, Macioce V, Faure S, Builles N, Lefebvre P, Geraud P, Picot MC, Rebuffat S, Renard E, Paradis V, Servais MD, de Preville N, Nocca D, Lajoix AD, Pageaux GP, Galtier F; COMET study group. The triglycerides and glucose (TyG) index: A new marker associated with nonalcoholic steatohepatitis (NASH) in obese patients. Diabetes Metab. 2022 Jul;48(4):101345. doi: 10.1016/j.diabet.2022.101345. Epub 2022 Mar 23.
PubMed 35339664
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of New Determinants of Type 2 Diabetes in Severe Obesity
- ClinicalTrials.gov ID
- NCT02861781
- Acronym / sponsor ID
- COMET / RECHMPL15_0271
- Conditions
- Obesity, Insulin Resistance, Diabetes Mellitus, Type 2
- Keywords
- Bariatric surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 2 Feb 2016 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 10 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetes | – | Other: Collection of blood samples and tissuesType 2 diabetes according to ADA criteria |
| Insulin resistance non diabetes | – | Other: Collection of blood samples and tissuesHOMA-IR criteria ≥ 3 |
| Insulin sensitivity non diabetes | – | Other: Collection of blood samples and tissuesHOMA-IR criteria < 3 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subject qualified for bariatric surgery
Key inclusion criteria (21 listed)
- Written informed consent
- Age 18 - 65 years inclusive at surgery
- IMC > 35
- Subject qualified for bariatric surgery (sleeve gastrectomy or gastric bypass)
- Specific criteria :
Key exclusion criteria (2 listed)
- Cancelled bariatric surgery
- Tissue collection not possible during the bariatric surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of blood samples and tissuesCollection of blood samples and tissues during bariatric surgery and blood samples during followup visits | Other | Insulin resistance non diabetes, Insulin sensitivity non diabetes, Type 2 diabetes |
Primary outcome
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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Background: PubMed 35339664Riviere B, Jaussent A, Macioce V, Faure S, Builles N, Lefebvre P, Geraud P, Picot MC, Rebuffat S, Renard E, Paradis V, Servais MD, de Preville N, Nocca D, Lajoix AD, Pageaux GP, Galtier F; COMET study group. The triglycerides and glucose (TyG) index: A new marker associated with nonalcoholic steatohepatitis (NASH) in obese patients. Diabetes Metab. 2022 Jul;48(4):101345. doi: 10.1016/j.diabet.2022.101345. Epub 2022 Mar 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Florence Galtier, MD contact
Florence GALTIER principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Insulin Resistance, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florence Galtier, MD (f-galtier@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of metabolites (time frame: At baseline (day of surgery)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02861781, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.