Clinical trial NCT05472883: Identification of Human Biomarkers Predictive of Diabetes Remission in Type 2 Diabetes Patient (BARIAKINES)
Official title: Identification of Human Circulating Adipocyte and Muscle Biomarkers Potentially Predictive of Diabetes Remission After Bariatric Surgery in Obese and Type 2 Diabetic Subjects.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Obesity
Bariatric Surgery Candidate
Proteins
Biomarkers
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2022-07-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is an exploratory pilot study, comparing for the first time in humans, the remission of type 2 diabetes, one year after bariatric surgery, with regard to circulating concentrations of 9 candidate proteins measured at T0.
Primary purpose: PREVENTION

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patients undergoing bariatric surgery will have 2 blood samples, a muscle sample and one adipose tissue sample withdrawn during the study.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

Eligibility criteria: 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.

Primary outcomes:
measure: Correlation between plasma levels of 9 target molecules and diabetes remission
timeFrame: Immediately before the Surgery (day 0)
measure: Correlation between plasma levels of 9 target molecules and diabetes remission
timeFrame: At 3 months post-surgery
measure: Correlation between plasma levels of 9 target molecules and diabetes remission
timeFrame: At 12 months post-surgery
Secondary outcomes:
measure: Areas under the ROC curves of different logistic regression models fitted to known clinical prediction scores (DiaRem, Ad-DiaRem).
timeFrame: At 3 months post-surgery
measure: Areas under the ROC curves of different logistic regression models fitted to known clinical prediction scores (DiaRem, Ad-DiaRem).
timeFrame: At 12 months post-surgery
measure: the kinetics of the plasma levels of each of the 9 molecules studied
timeFrame: Immediately before the Surgery (day 0)
measure: the kinetics of the plasma levels of each of the 9 molecules studied
timeFrame: At 3 months after the surgery
measure: the kinetics of the plasma levels of each of the 9 molecules studied
timeFrame: At 12 months after the surgery
measure: The expression level of genes encoding 9 biomarkers in the adipocyte and the muscle cell
timeFrame: At the day of the inclusion
measure: The expression level of genes encoding 9 biomarkers in the adipocyte and the muscle cell
timeFrame: At 3 months after surgery
measure: The expression level of genes encoding 9 biomarkers in the adipocyte and the muscle cell
timeFrame: At 12 months after surgery
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Toulouse University Hospital
Study officials:
affiliation: University Hospital, Toulouse
name: Emilie MONTASTIER, MD
role: PRINCIPAL_INVESTIGATOR
References: