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

Primary Purpose

Type 2 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood samples
collection of body tissues
routine care procedure
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes focused on measuring Obesity, Bariatric Surgery Candidate, Proteins, Biomarkers

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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
  • 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.

Sites / Locations

  • Toulouse University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

study arm

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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
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
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

Full Information

First Posted
June 13, 2022
Last Updated
March 8, 2023
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT05472883
Brief Title
Identification of Human Biomarkers Predictive of Diabetes Remission in Type 2 Diabetes Patient (BARIAKINES)
Acronym
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 27, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Obesity, Bariatric Surgery Candidate, Proteins, Biomarkers

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
study arm
Arm Type
Experimental
Arm Description
This arm consists of obese patients with type 2 diabetes who are scheduled for bariatric surgery.
Intervention Type
Procedure
Intervention Name(s)
blood samples
Intervention Description
- Research blood sample: 2 additional tubes compared to the classic sample for the analysis of the 9 research molecules.
Intervention Type
Procedure
Intervention Name(s)
collection of body tissues
Intervention Description
removal of intra-abdominal fat and muscle tissue
Intervention Type
Procedure
Intervention Name(s)
routine care procedure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Correlation between plasma levels of 9 target molecules and diabetes remission
Description
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.
Time Frame
Immediately before the Surgery (day 0)
Title
Correlation between plasma levels of 9 target molecules and diabetes remission
Description
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.
Time Frame
At 3 months post-surgery
Title
Correlation between plasma levels of 9 target molecules and diabetes remission
Description
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.
Time Frame
At 12 months post-surgery
Secondary Outcome Measure Information:
Title
Areas under the ROC curves of different logistic regression models fitted to known clinical prediction scores (DiaRem, Ad-DiaRem).
Description
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.
Time Frame
At 3 months post-surgery
Title
Areas under the ROC curves of different logistic regression models fitted to known clinical prediction scores (DiaRem, Ad-DiaRem).
Description
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.
Time Frame
At 12 months post-surgery
Title
the kinetics of the plasma levels of each of the 9 molecules studied
Description
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.
Time Frame
Immediately before the Surgery (day 0)
Title
the kinetics of the plasma levels of each of the 9 molecules studied
Description
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.
Time Frame
At 3 months after the surgery
Title
the kinetics of the plasma levels of each of the 9 molecules studied
Description
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.
Time Frame
At 12 months after the surgery
Title
The expression level of genes encoding 9 biomarkers in the adipocyte and the muscle cell
Description
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
Time Frame
At the day of the inclusion
Title
The expression level of genes encoding 9 biomarkers in the adipocyte and the muscle cell
Description
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
Time Frame
At 3 months after surgery
Title
The expression level of genes encoding 9 biomarkers in the adipocyte and the muscle cell
Description
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
Time Frame
At 12 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emilie MONTASTIER, Ph
Phone
05 61 32 30 89
Email
montastier.e@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emilie MONTASTIER
Organizational Affiliation
Toulouse University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toulouse University Hospital
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emilie MONTASTIER, Ph

12. IPD Sharing Statement

Learn more about this trial

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

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