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

July 12, 2019 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussel, Belgium, 1200
        • Recruiting
        • Cliniques universitaires Saint-Luc
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Level of myokines in culture media conditioned by muscle cells taken before and 3 months after bariatric surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2017

Primary Completion (Anticipated)

October 1, 2021

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

November 9, 2017

First Submitted That Met QC Criteria

November 13, 2017

First Posted (Actual)

November 14, 2017

Study Record Updates

Last Update Posted (Actual)

July 15, 2019

Last Update Submitted That Met QC Criteria

July 12, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/24AOU/417

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

There no plan at this moment

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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