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Taking people in FranceNo phase

Studies tissue and blood samples from people with obesity and type 2 diabetes

Collects blood and tissue samples during bariatric surgery to study diabetes in severe obesity.

Key facts

Who runs it
University Hospital, Montpellier
Where
Montpellier, FranceSee the site
Trial code
Registry title
Collection of Human Metabolic Tissues
Status
Recruiting
People taking part
270 people, planned
Started
2 Feb 2016
Expected to end
Sept 2028
Type of study
Observational, 3 groups
Treatments tested
  • Collection of blood samples and tissues
Record updated
8 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with severe obesity who are going to have weight-loss surgery (sleeve gastrectomy or gastric bypass). Three groups are formed: type 2 diabetes, insulin resistance, and insulin sensitivity.

Age
18 to 65 years at the time of surgery.
Sex
All sexes can join.
Disease stage
Severe obesity (BMI over 35) and qualified for sleeve gastrectomy or gastric bypass. Groups: type 2 diabetes by ADA criteria, no diabetes with HOMA-IR 3 or higher, or no diabetes with HOMA-IR below 3.
Earlier treatment
People who had earlier weight-loss surgery cannot join, except a lap-band procedure.
Biomarker or test result
HOMA-IR 3 or higher (insulin resistance group) or HOMA-IR below 3 (insulin sensitivity group). The type 2 diabetes group is defined by ADA criteria.

Main reasons for not taking part

  • Hepatitis B, hepatitis C or HIV infection
  • Inflammatory, infectious or autoimmune disease now or in the last 3 months
  • Cancer within the last 5 years, or not treated with the aim of removing all of the disease
  • Steroid or NSAID use, including in the 8 days before surgery
  • Alcohol abuse or addiction

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Cancelled bariatric surgery
  • Tissue collection not possible during the bariatric surgery

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 65 years old?

Where in France

  • Hôpital Saint EloiMontpellier, FranceContact: Florence Galtier, MDTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 3 groups in the trial

  • Type 2 diabetes

    Type 2 diabetes according to ADA criteria

    Treatment: Collection of blood samples and tissues

  • Insulin resistance non diabetes

    HOMA-IR criteria ≥ 3

    Treatment: Collection of blood samples and tissues

  • Insulin sensitivity non diabetes

    HOMA-IR criteria \< 3

    Treatment: Collection of blood samples and tissues

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Study of New Determinants of Type 2 Diabetes in Severe Obesity
Plain-language title
Studies tissue and blood samples from people with obesity and type 2 diabetesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT02861781, who can take part
Record updated
8 May 2026