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

Not Applicable

Recruiting

• Conditions: Type 2 Diabetes
• Interventions: Procedure: blood samples; Procedure: collection of body tissues; Procedure: routine care procedure

• Registration Number: NCT05472883
• Lead Sponsor: University Hospital, Toulouse

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patients undergoing bariatric surgery will have 2 blood samples, a muscle sample and one adipose tissue sample withdrawn during the study.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

Study Timeline

• Study First Submitted: 2022-06-13
• Study First Submitted QC: 2022-07-21
• Study First Posted: 2022-07-25
• Study Start: 2023-02-27
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-14
• Last Update Posted: 2024-06-17
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
study arm	blood samples	This arm consists of obese patients with type 2 diabetes who are scheduled for bariatric surgery.
study arm	routine care procedure	This arm consists of obese patients with type 2 diabetes who are scheduled for bariatric surgery.
study arm	collection of body tissues	This arm consists of obese patients with type 2 diabetes who are scheduled for bariatric surgery.

Primary Outcome Measures

Name	Time	Method
Correlation between plasma levels of 9 target molecules and diabetes remission	At 12 months post-surgery	The correlation between plasma levels of 9 target molecules (1 for each molecule) and diabetes remission will be evaluated will be evaluated through plasmatic dosages.; The plasma determination of apolipoprotein M will be performed by mass spectrometry, and the 8 other molecules will be determined by the ELISA technique. The dosage is measured in mmol/l.; Complete remission of T2DM will be defined according to the following criteria: HbA1c \< 5.7% and fasting blood glucose \< 5.6 mmol/l.; Partial remission of T2DM will be defined as: HbA1c between 5.7 and 6.5% and fasting blood glucose between 5.6 and 6.9 mmol/l without any antidiabetic treatment. Finally, the absence of remission will include patients whose HbA1c is greater than or equal to 6.5% or fasting blood glucose greater than or equal to 7 mmol/l with one or more antidiabetic treatments.

Secondary Outcome Measures

Name	Time	Method
Areas under the ROC curves of different logistic regression models fitted to known clinical prediction scores (DiaRem, Ad-DiaRem).	At 12 months post-surgery	The DiaRem and Ad-DiaRem scores are weighted scoring systems based on initial pre-surgical factors that were specifically created to predict remission of type 2 diabetes after bariatric surgery.
The expression level of genes encoding 9 biomarkers in the adipocyte and the muscle cell	At 12 months after surgery	The expression level of the genes encoding 9 biomarkers in the adipocyte and the muscle cell will be evaluated by measuring the mRNA quantities of the genes of these 9 proteins
the kinetics of the plasma levels of each of the 9 molecules studied	At 12 months after the surgery	the kinetics of the plasma levels of each of the 9 molecules will be studied by measuring each factor on an empty stomach: the day of the operation in the digestive surgery department.

Trial Locations

Locations (1)

Toulouse University Hospital; 🇫🇷 Toulouse, France