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RecruitingNCT05472883

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

Identification of Human Circulating Adipocyte and Muscle Biomarkers Potentially Predictive of Diabetes Remission After Bariatric Surgery in Obese and Type 2 Diabetic Subjects.

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
50 (estimated)
Sponsor
University Hospital, Toulouse · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed 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diabetes patients undergoing bariatric surgery will have 2 blood samples, a muscle sample and one adipose tissue sample withdrawn during the study.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

Conditions

Interventions

TypeNameDescription
PROCEDUREblood samples\- Research blood sample: 2 additional tubes compared to the classic sample for the analysis of the 9 research molecules.
PROCEDUREcollection of body tissuesremoval of intra-abdominal fat and muscle tissue
PROCEDUREroutine care procedure* Routine care blood sample: Full vitamin panel, CBC, liver panel, urea, creatinine, blood ionogram, blood calcium, phosphorus, magnesium at all visits, except the morning of surgery when only ß HCG (for women of childbearing age), HbA1c. * clinical examination : weight, height, waist measurement, cardiovascular examination, digestive system examination. * dosage of ß HCG for womens.

Timeline

Start date
2023-02-27
Primary completion
2025-12-31
Completion
2025-12-31
First posted
2022-07-25
Last updated
2025-12-31

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT05472883. Inclusion in this directory is not an endorsement.