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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Procedure: blood samples; Procedure: collection of body tissues; Procedure: routine care procedure

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diabetes patients undergoing bariatric surgery will have 2 blood samples, a muscle sample and one adipose tissue sample withdrawn during the study.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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emilie MONTASTIER, Ph; Phone Number: 05 61 32 30 89; Email: montastier.e@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France, 31059
    • Recruiting
    • Toulouse University Hospital
    • Principal Investigator: Emilie MONTASTIER, Ph

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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
• Over 18 and under 70 years of age
• Affiliated or beneficiaries of a social security plan.
• Having provided a free, informed and written consent, signed (at the latest on the day of inclusion and before any examination required by the research).

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Procedure: blood samples; - Research blood sample: 2 additional tubes compared to the classic sample for the analysis of the 9 research molecules.; Procedure: collection of body tissues; removal of intra-abdominal fat and muscle tissue; Procedure: routine 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between plasma levels of 9 target molecules and diabetes remission	The correlation between plasma levels of 9 target molecules (1 for each molecule) and diabetes remission 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.	Immediately before the Surgery (day 0)
Correlation between plasma levels of 9 target molecules and diabetes remission	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.	At 3 months post-surgery
Correlation between plasma levels of 9 target molecules and diabetes remission	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.	At 12 months post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Areas under the ROC curves of different logistic regression models fitted to known clinical prediction scores (DiaRem, Ad-DiaRem).	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.	At 3 months post-surgery
Areas under the ROC curves of different logistic regression models fitted to known clinical prediction scores (DiaRem, Ad-DiaRem).	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.	At 12 months post-surgery
the kinetics of the plasma levels of each of the 9 molecules studied	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.	Immediately before the Surgery (day 0)
the kinetics of the plasma levels of each of the 9 molecules studied	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.	At 3 months after the surgery
the kinetics of the plasma levels of each of the 9 molecules studied	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.	At 12 months after the surgery
The expression level of genes encoding 9 biomarkers in the adipocyte and the muscle cell	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	At the day of the inclusion
The expression level of genes encoding 9 biomarkers in the adipocyte and the muscle cell	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	At 3 months after surgery
The expression level of genes encoding 9 biomarkers in the adipocyte and the muscle cell	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	At 12 months after surgery

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Emilie MONTASTIER, Toulouse University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2023
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: June 13, 2022
• First Submitted That Met QC Criteria: July 21, 2022
• First Posted (Actual): July 25, 2022

Study Record Updates

• Last Update Posted (Estimate): March 10, 2023
• Last Update Submitted That Met QC Criteria: March 8, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Obesity; Biomarkers; Bariatric Surgery Candidate; Proteins
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: RC31/21/0614

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No