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

NCT05472883 | Recruiting

• 1 other identifier: RC31/21/0614
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

Obesity; Bariatric Surgery Candidate; Proteins; Biomarkers

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Areas under the ROC curves of different logistic regression models fitted to known clinical prediction scores (DiaRem, Ad-DiaRem).

  At 3 months post-surgery

• 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 kinetics of the plasma levels of each of the 9 molecules studied

  Immediately before the Surgery (day 0)

• the kinetics of the plasma levels of each of the 9 molecules studied

  At 3 months after the surgery

• the kinetics of the plasma levels of each of the 9 molecules studied

  At 12 months after the surgery

Study Arms (1)

study arm

EXPERIMENTAL

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

Procedure: blood samples; Procedure: collection of body tissues; Procedure: routine care procedure

Interventions

blood samples PROCEDURE

\- Research blood sample: 2 additional tubes compared to the classic sample for the analysis of the 9 research molecules.

study arm

collection of body tissues PROCEDURE

removal of intra-abdominal fat and muscle tissue

study arm

routine care procedure 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.

study arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Toulouse University Hospital

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Emilie MONTASTIER, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilie MONTASTIER, MD

CONTACT

05 61 32 30 89; montastier.e@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: July 25, 2022
• Study Start: February 27, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

FR (1)