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Impact of Changes in Muscle Secretome in the Remission of Type 2 Diabetes Mellitus Induced by Bariatric Surgery (MYDIASECRET)

C

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status

Unknown

Conditions

Diabete Type 2

Treatments

Diagnostic Test: Muscle biopsy and blood test

Study type

Interventional

Funder types

Other

Identifiers

NCT03341793
2017/24AOU/417

Details and patient eligibility

About

Bariatric surgery is recognized as a therapeutic modality of type 2 diabetes. The mechanisms of this remission of diabetes remain poorly understood.

The aim of our research is to characterize the changes in muscle secretome induced by bariatric surgery and to determine their role in improving the insulin sensitivity of skeletal muscle and insulin secretion by the B cell responsible for the remission of diabetes.

Full description

Bariatric surgery is recognized as a therapeutic modality of type 2 diabetes. The mechanisms of this remission of diabetes remain poorly understood.

The aim of our research is to characterize the changes in muscle secretome induced by bariatric surgery and to determine their role in improving the insulin sensitivity of skeletal muscle and insulin secretion by the B cell responsible for the remission of diabetes.

This prospective study will be carried out in insulin-resistant diabetic patients or not in whom blood and muscle samples will be carried out before and after bariatric surgery

Enrollment

40 estimated patients

Sex

All

Ages

18 to 69 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age from 19 to 69 year-old Candidate for bariatric surgery BMI ≥ 35kg / m² with at least one subsequent comorbidity (SAS or type 2 diabetes mellitus or refractory HTA) or BMI ≥ 40kg / m² Non-diabetic or diabetic with HbA1c <7.5% without treatment except metformin Caucasian No pregnancy or breastfeeding No history of neoplasia in the last 5 years No history of uncontrolled endocrinopathy other than diabetes Informed consent signed by patient

Exclusion criteria

  • Non-caucasian Major Depression Hemorrhagic risk (biopsy) associated with taking anticoagulants/antiaggregants Known myopathy Systemic administration of steroids (> 1mg/kg in hydrocortisone) Hyperthyroidism Type 1 diabetes Psychological, familial, sociological or geographical condition potentially limiting compliance with the protocol Participation in other clinical drug studies Modification of anti-diabetic treatment during the month preceding surgery

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

Muscle secretion
Experimental group
Description:
Characterize the changes in muscle secretion induced by bariatric surgery and determine their role in improving the insulin sensitivity of skeletal muscle and insulin secretion by B cell responsible for the remission of diabetes mellitus.
Treatment:
Diagnostic Test: Muscle biopsy and blood test

Trial contacts and locations

1

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Central trial contact

Marie de Barsy, Nurse; Jean-Paul Thissen, MD, PhD

Data sourced from clinicaltrials.gov

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