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

NCT ID: NCT05472883

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-27

Study Completion Date

2025-12-31

Brief Summary

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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

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patients undergoing bariatric surgery will have 2 blood samples, a muscle sample and one adipose tissue sample withdrawn during the study.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

Conditions

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Type 2 Diabetes

Keywords

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Obesity Bariatric Surgery Candidate Proteins Biomarkers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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study arm

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

Group Type EXPERIMENTAL

blood samples

Intervention Type PROCEDURE

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

collection of body tissues

Intervention Type PROCEDURE

removal of intra-abdominal fat and muscle tissue

routine care procedure

Intervention Type 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.

Interventions

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blood samples

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

Intervention Type PROCEDURE

collection of body tissues

removal of intra-abdominal fat and muscle tissue

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emilie MONTASTIER, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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Toulouse University Hospital

Toulouse, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Emilie MONTASTIER, MD

Role: CONTACT

Phone: 05 61 32 30 89

Email: [email protected]

Other Identifiers

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RC31/21/0614

Identifier Type: -

Identifier Source: org_study_id