NCT02861781Recruiting
Collection of Human Metabolic Tissues
Study of New Determinants of Type 2 Diabetes in Severe Obesity
Source: ClinicalTrials.gov · Last updated 8 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 270 (estimated)
- First submitted
- 2 Aug 2016
- Start date
- 2 Feb 2016
- Primary completion date
- Sept 2028
- Lead sponsor
- University Hospital, Montpellier
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT02861781
What you commit to
- Study type: Observational
- Planned participants: 270
- From 2 Feb 2016 to the primary completion date, Sept 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Cancelled bariatric surgery
- Tissue collection not possible during the bariatric surgery
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Saint Eloi Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.