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

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ClinicalTrials.gov Identifier: NCT03341793
Recruitment Status : Unknown
Verified July 2019 by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Recruitment status was:  Recruiting
First Posted : November 14, 2017
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Diabete Type 2 Diagnostic Test: Muscle biopsy and blood test Not Applicable

Detailed 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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Impact of Changes in Muscle Secretome in the Remission of Type 2 Diabetes Mellitus Induced by Bariatric Surgery
Actual Study Start Date : November 14, 2017
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Muscle secretion
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.
 Diagnostic Test: Muscle biopsy and blood test
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.


Outcome Measures
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Primary Outcome Measures :
  1. Changes in myokine (muscle secretome) secretion induced by bariatric surgery [ Time Frame: Level of myokines in culture media conditioned by muscle cells taken before and 3 months after bariatric surgery. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03341793


Contacts
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Contact: Jean-Paul Thissen, MD, PhD 0032 2 7654 ext 1812 jeanpaul.thissen@uclouvain.be
Contact: Marie de Barsy, Nurse 0032 2764 ext 5424 marie.debarsy@uclouvain.be

Locations
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Belgium
Cliniques universitaires Saint-Luc Recruiting
Brussel, Belgium, 1200
Contact: Jean-Paul Thissen, MD, PhD    0032 2764 ext 1812    jeanpaul.thissen@uclouvain.be   
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
More Information
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Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT03341793    
Other Study ID Numbers: 2017/24AOU/417
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: There no plan at this moment

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases