Identification of Human Biomarkers Predictive of Diabetes Remission in Type 2 Diabetes Patient (BARIAKINES)

Toulouse University Hospital

Status: Enrolling

Conditions: Type 2 Diabetes

Treatments: Procedure: blood samples; Procedure: routine care procedure; Procedure: collection of body tissues

Study type: Interventional

Funder types: Other

Identifiers

NCT05472883

RC31/21/0614

Details and patient eligibility

About

This study focuses on identifying potentially predictive human circulating adipocyte and muscle biomarkers of diabetes remission after bariatric surgery in obese type 2 diabetic (T2D) subjects.

Full description

The study team at the Institute of Metabolic and Cardiovascular Diseases has recently identified several potential biomarkers (secreted by skeletal muscle and adipose tissue) of glucose homeostasis control using secretomic and metabolomic analyses. The goal of this study is to assess whether the addition of 9 adipocytes and myocytes plasma level could be associated with type 2 diabetes remission one year after bariatric surgery and would improve established clinical models of prediction of diabetes remission.

Thus, obese type 2 diabetes patients undergoing bariatric surgery will have 2 blood samples, a muscle sample and one adipose tissue sample withdrawn during the study. From those samples, concentrations of 9 candidate proteins is measured : GDF6, INHBB, IL17B, TGFB2, TIMP1, VTN, MDK, GDF15, and apoM

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Obese patients of at least grade 2 (body mass index ≥ 35 kg/m²)
• Type 2 diabetics
• About to undergo bariatric surgery at the Toulouse University Hospital
• Affiliated or beneficiaries of a social security plan.
• Having provided a free, informed and written consent, signed

Exclusion criteria

• Type 1 diabetic subjects or Maturity-Onset Diabetes of the Youth.
• Pregnant and breastfeeding women.
• Vulnerable persons as defined in the Public Health Code: protected adults (guardianship, curators), unable to express their consent.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

study arm

Experimental group

Description:

This arm consists of obese patients with type 2 diabetes who are scheduled for bariatric surgery.

Treatment:

Procedure: collection of body tissues

Procedure: routine care procedure

Procedure: blood samples