Collection of Human Metabolic Tissues

NCT ID: NCT02861781

Last Updated: 2025-01-17

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 270 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-02-02
• Study Completion Date: 2028-09-30

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.

Conditions

Obesity; Insulin Resistance; Diabetes Mellitus, Type 2

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Type 2 diabetes

Type 2 diabetes according to ADA criteria

Collection of blood samples and tissues

Intervention Type: OTHER

Collection of blood samples and tissues during bariatric surgery and blood samples during followup visits

Insulin resistance non diabetes

HOMA-IR criteria ≥ 3

Collection of blood samples and tissues

Intervention Type: OTHER

Collection of blood samples and tissues during bariatric surgery and blood samples during followup visits

Insulin sensitivity non diabetes

HOMA-IR criteria \< 3

Collection of blood samples and tissues

Intervention Type: OTHER

Collection of blood samples and tissues during bariatric surgery and blood samples during followup visits

Interventions

Collection of blood samples and tissues

Collection of blood samples and tissues during bariatric surgery and blood samples during followup visits

Intervention Type: OTHER

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Florence GALTIER

Role: PRINCIPAL_INVESTIGATOR

Montpellier University Hospital

Locations

Hôpital Saint Eloi

Montpellier, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Florence Galtier, MD

Role: CONTACT

f-galtier@chu-montpellier.fr

Facility Contacts

Florence Galtier, MD

Role: primary

f-galtier@chu-montpellier.fr

Other Identifiers

2015-A01193-46

Identifier Type: OTHER

Identifier Source: secondary_id

UF 9605

Identifier Type: OTHER

Identifier Source: secondary_id

RECHMPL15_0271

Identifier Type: -

Identifier Source: org_study_id