Diabete Type 2MYDIASECRETNCT03341793
Impact of Changes in Muscle Secretome in the Remission of Type 2 Diabetes Mellitus Induced by Bariatric Surgery
A study testing Muscle biopsy and blood test in people with Diabete Type 2, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Diabete Type 2
- What is being tested?
- Muscle biopsy and blood test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 14 Nov 2017to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques universitaires Saint-Luc
Brussels, 1200
Jean-Paul Thissen, MD, PhD, 0032 2764 ext. 1812, jeanpaul.thissen@uclouvain.be
About this study
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.
Read the 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
- Conditions
- Diabete Type 2
- Being tested
- Muscle biopsy and blood test
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle biopsy and blood testDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Muscle secretion | Experimental | 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. Receives: Diagnostic Test: Muscle biopsy and blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in myokine (muscle secretome) secretion induced by bariatric surgery
Measured: Level of myokines in culture media conditioned by muscle cells taken before and 3 months after bariatric surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start14 Nov 2017
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabete Type 2Studies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03341793
- Sponsor's protocol ID
- 2017/24AOU/417
- Acronym
- MYDIASECRET
- Status last verified
- Jul 2019
- First submitted
- 9 Nov 2017
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: There no plan at this moment
Publications
Orioli L, Canouil M, Sawadogo K, Ning L, Deldicque L, Lause P, de Barsy M, Froguel P, Loumaye A, Deswysen Y, Navez B, Bonnefond A, Thissen JP. Identification of myokines susceptible to improve glucose homeostasis after bariatric surgery. Eur J Endocrinol. 2023 Sep 1;189(3):409-421. doi: 10.1093/ejendo/lvad122.
PubMed 37638789
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Changes in Muscle Secretome in the Remission of Type 2 Diabetes Mellitus Induced by Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03341793
- Acronym / sponsor ID
- MYDIASECRET / 2017/24AOU/417
- Conditions
- Diabete Type 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 14 Nov 2017 (actual)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 14 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Muscle secretion | Experimental | Diagnostic Test: Muscle biopsy and blood testCharacterize 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. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscle biopsy and blood testCharacterize 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 secretion |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
- Derived from this study: PubMed 37638789Orioli L, Canouil M, Sawadogo K, Ning L, Deldicque L, Lause P, de Barsy M, Froguel P, Loumaye A, Deswysen Y, Navez B, Bonnefond A, Thissen JP. Identification of myokines susceptible to improve glucose homeostasis after bariatric surgery. Eur J Endocrinol. 2023 Sep 1;189(3):409-421. doi: 10.1093/ejendo/lvad122.
- Individual participant dataSharing planned: Undecided. There no plan at this moment
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle biopsy and blood test in people with Diabete Type 2, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Paul Thissen, MD, PhD (0032 2 7654 ext. 1812, jeanpaul.thissen@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03341793, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2019.