Collection of Human Metabolic Tissues

NCT02861781 | Recruiting

• 3 other identifiers: RECHMPL15_02712015-A01193-46UF 9605
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 1

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

Keywords

Bariatric surgery

Outcome Measures

Primary Outcomes (3)

• comparison of metabolites

  At baseline (day of surgery)

• comparison of proteins levels

  in liver, muscle, adipose tissue and plasma according to metabolic state

  At baseline (day of surgery)

• comparison of miRNA

  in liver, muscle, adipose tissue and plasma according to metabolic state

  At baseline (day of surgery)

Secondary Outcomes (3)

• changes in metabolites in plasma level

  3 and 12 months after the completion of surgery

• changes in proteins in plasma level

  3 and 12 months after the completion of surgery

• changes in miRNA in plasma level

  3 and 12 months after the completion of surgery

Study Arms (3)

Type 2 diabetes

Type 2 diabetes according to ADA criteria

Other: Collection of blood samples and tissues

Insulin resistance non diabetes

HOMA-IR criteria ≥ 3

Other: Collection of blood samples and tissues

Insulin sensitivity non diabetes

HOMA-IR criteria \< 3

Other: Collection of blood samples and tissues

Interventions

Collection of blood samples and tissues OTHER

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

Insulin resistance non diabetes; Insulin sensitivity non diabetes; Type 2 diabetes

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subject qualified for bariatric surgery

You may qualify if:

• 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
• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Hôpital Saint Eloi

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Obesity; Insulin Resistance; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Florence GALTIER

  Montpellier University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Florence Galtier, MD

CONTACT

f-galtier@chu-montpellier.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2016
• First Posted: August 10, 2016
• Study Start: February 2, 2016
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: January 17, 2025

Record last verified: 2025-01

Locations

FR (1)