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

Type 2 Diabetes Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05472883
• Other study ID #: RC31/21/0614
• Status: Recruiting
• Phase: N/A
• Start date: February 27, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: University Hospital, Toulouse
• Contact: Emilie MONTASTIER, MD
• Phone: 05 61 32 30 89
• Email: montastier.e[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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patients undergoing bariatric surgery will have 2 blood samples, a muscle sample and one adipose tissue sample withdrawn during the study.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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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

Locations

Country	Name	City	State
France	Toulouse University Hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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