ObesityMISTRALNCT02332434
Effects of Various Bariatric Surgical Procedures on Intestinal TRL Metabolism in Obese Type 2 Diabetic Patients
A study testing stable isotope enrichment methodology (5,5,5-D3-L-Leucine) in people with Obesity and Diabetes, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Rational: The world and french epidemic of obesity and diabetes represents a major problem of public health. The prevalence in France, in the adult population, is 15 % corresponding to 6.9 million people for obesity and 6 % corresponding to 3.9 million people for diabetes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- stable isotope enrichment methodology (5,5,5-D3-L-Leucine)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2015to Jan 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject with a body mass index between 35 and 60 kg / m²
- Subject with no contradiction to the 2 surgical techniques studied: Sleeve Gastrectomy and Gastric Bypass
- Subject with type 2 diabetes as defined
- Subject not having presented cardiovascular events (myocardial infarct, stroke, peripheral ischemia) in the previous 6 months
Who cannot join
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Sophie Beliard, MD contact
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hôpitaux Marseille
Marseille, 13005
Sophie BELIARD, MD, sophie.beliard@ap-hm.fr
About this study
Official title: Effects of Various Bariatric Surgical Procedures on Intestinal Triglyceride-rich-lipoprotein (TRL) Metabolism in Obese Type 2 Diabetic Patients
Rational: The world and french epidemic of obesity and diabetes represents a major problem of public health. The prevalence in France, in the adult population, is 15 % corresponding to 6.9 million people for obesity and 6 % corresponding to 3.9 million people for diabetes. Morbidly obesity (body mass index 40 kg/m²), the most serious, is more and more frequent. Cardiovascular diseases are the first cause of morbidity and mortality. The atherogenic dyslipidemia of these insulin-resistant obese type 2 diabetic patients characterized by the quartet: elevated plasma triglycerides, low high-density lipoprotein-cholesterol, increased proportion of small and dense low-density lipoproteins, is widely explained by the blood accumulation of TRL from the liver and the intestine, and represents a major cardiovascular risk factor. The overproduction of intestinal TRL (which apoprotein B48 is the specific tracer) is a constituent recently recognized of insulin-resistance and the atherogenous role of these intestinal TRL has been shown. In view of this important overmortality and the failures of the medical, nutritional, dietary and psychotherapeutic combined treatment, the bariatric surgery quickly developed. Two main procedures are performed: 1 based exclusively on the gastric restriction (the sleeve gastrectomy) and one associating a malabsorption (the gastric bypass).
Objectives: The main objective of this study is to compare the effect of each surgical procedure and the differential effect of the 2 bariatric surgery procedures on the production and clearance rates of the intestinal TRL. The secondary objectives are to compare the effect of each surgical procedure and the differential effect of the 2 bariatric surgery procedures on the production and clearance rates of the hepatic TRL and to document the potential links between the expected reduction of these productions after the surgery and the loss of weight, the improvement of the insulin-sensitivity, the changes in hormones, the decrease of the inflammatory state, the changes in energy expenditure, body composition and energy intake.
Read more
Methods: It is a multicentric, prospective, comparative study of cohorts. After identification of the eligible subjects, the kinetics (production and clearance rates) of intestinal and hepatic TRL will be performed in the hospital, using established stable isotope enrichment methodology (5,5,5-D3-L-Leucine), in 2 groups of obese patients (15 patients per surgery procedure), before and 6 months after the surgery.
Perspectives: A better understanding of the dyslipidemia of obese type 2 diabetic patients and the factors modulating this dyslipidemia may lead to develop new dietary and/or drugs and/or surgical treatments targeted at the enterocyte to improve the lipid profile of these patients and reduce the incidence of cardiovascular diseases. Moreover, a differential effect between the 2 surgical procedures could help to choose the best surgical procedure for obese type 2 diabetic patients depending on the lipid profile at baseline.
- Being tested
- stable isotope enrichment methodology (5,5,5-D3-L-Leucine)
- Medical subject headings
- Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stable isotope enrichment methodology (5,5,5-D3-L-Leucine)Other
| Study group | Role | What they receive |
|---|---|---|
| sleeve gastrectomy | Experimental | bariatric surgery procedure based exclusively on the gastric restriction (the sleeve gastrectomy). Receives: Other: stable isotope enrichment methodology (5,5,5-D3-L-Leucine) |
| gastric bypass | Experimental | bariatric surgery procedure associating a malabsorption (the gastric bypass). Receives: Other: stable isotope enrichment methodology (5,5,5-D3-L-Leucine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
production and clearance rates of intestinal and hepatic TRL, in 2 groups of obese patients (15 patients per surgery procedure), before and 6 months after the surgery.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startMar 2015
- Primary completionJan 2018 (estimated)
- Study completionJan 2019 (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 ObesityStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle Desalbres, Study director, Assistance Publique Hôpitaux Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02332434
- Sponsor's protocol ID
- 2014-15
- Other IDs
- RCAPHM14_0179
- Acronym
- MISTRAL
- Status last verified
- Nov 2015
- First submitted
- 5 Jan 2015
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Frances L, Croyal M, Ruidavets JB, Maraninchi M, Combes G, Raffin J, de Souto Barreto P, Ferrieres J, Blaak EE, Perret B, Moro C, Valero R, Martinez LO, Viguerie N. Identification of circulating apolipoprotein M as a new determinant of insulin sensitivity and relationship with adiponectin. Int J Obes (Lond). 2024 Jul;48(7):973-980. doi: 10.1038/s41366-024-01510-w. Epub 2024 Mar 15.
PubMed 38491190
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Various Bariatric Surgical Procedures on Intestinal Triglyceride-rich-lipoprotein (TRL) Metabolism in Obese Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT02332434
- Acronym / sponsor ID
- MISTRAL / 2014-15
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 6 Jan 2015 (estimated)
- 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.
Rational: The world and french epidemic of obesity and diabetes represents a major problem of public health. The prevalence in France, in the adult population, is 15 % corresponding to 6.9 million people for obesity and 6 % corresponding to 3.9 million people for diabetes. Morbidly obesity (body mass index 40 kg/m²), the most serious, is more and more frequent. Cardiovascular diseases are the first cause of morbidity and mortality. The atherogenic dyslipidemia of these insulin-resistant obese type 2 diabetic patients characterized by the quartet: elevated plasma triglycerides, low high-density lipoprotein-cholesterol, increased proportion of small and dense low-density lipoproteins, is widely explained by the blood accumulation of TRL from the liver and the intestine, and represents a major cardiovascular risk factor. The overproduction of intestinal TRL (which apoprotein B48 is the specific tracer) is a constituent recently recognized of insulin-resistance and the atherogenous role of these intestinal TRL has been shown. In view of this important overmortality and the failures of the medical, nutritional, dietary and psychotherapeutic combined treatment, the bariatric surgery quickly developed. Two main procedures are performed: 1 based exclusively on the gastric restriction (the sleeve gastrectomy) and one associating a malabsorption (the gastric bypass).
Objectives: The main objective of this study is to compare the effect of each surgical procedure and the differential effect of the 2 bariatric surgery procedures on the production and clearance rates of the intestinal TRL. The secondary objectives are to compare the effect of each surgical procedure and the differential effect of the 2 bariatric surgery procedures on the production and clearance rates of the hepatic TRL and to document the potential links between the expected reduction of these productions after the surgery and the loss of weight, the improvement of the insulin-sensitivity, the changes in hormones, the decrease of the inflammatory state, the changes in energy expenditure, body composition and energy intake.
Methods: It is a multicentric, prospective, comparative study of cohorts. After identification of the eligible subjects, the kinetics (production and clearance rates) of intestinal and hepatic TRL will be performed in the hospital, using established stable isotope enrichment methodology (5,5,5-D3-L-Leucine), in 2 groups of obese patients (15 patients per surgery procedure), before and 6 months after the surgery.
Perspectives: A better understanding of the dyslipidemia of obese type 2 diabetic patients and the factors modulating this dyslipidemia may lead to develop new dietary and/or drugs and/or surgical treatments targeted at the enterocyte to improve the lipid profile of these patients and reduce the incidence of cardiovascular diseases. Moreover, a differential effect between the 2 surgical procedures could help to choose the best surgical procedure for obese type 2 diabetic patients depending on the lipid profile at baseline.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sleeve gastrectomy | Experimental | Other: stable isotope enrichment methodology (5,5,5-D3-L-Leucine)bariatric surgery procedure based exclusively on the gastric restriction (the sleeve gastrectomy). |
| gastric bypass | Experimental | Other: stable isotope enrichment methodology (5,5,5-D3-L-Leucine)bariatric surgery procedure associating a malabsorption (the gastric bypass). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject with a body mass index between 35 and 60 kg / m²
- Subject with no contradiction to the 2 surgical techniques studied: Sleeve Gastrectomy and Gastric Bypass
- Subject with type 2 diabetes as defined
- Subject not having presented cardiovascular events (myocardial infarct, stroke, peripheral ischemia) in the previous 6 months
Key exclusion criteria (1 listed)
- Pregnant women
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 |
|---|---|---|
| stable isotope enrichment methodology (5,5,5-D3-L-Leucine) | Other | gastric bypass, sleeve gastrectomy |
Primary outcome
production and clearance rates of intestinal and hepatic TRL, in 2 groups of obese patients (15 patients per surgery procedure), before and 6 months after the surgery.
Time frame: 7 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2015.
- Derived from this study: PubMed 38491190Frances L, Croyal M, Ruidavets JB, Maraninchi M, Combes G, Raffin J, de Souto Barreto P, Ferrieres J, Blaak EE, Perret B, Moro C, Valero R, Martinez LO, Viguerie N. Identification of circulating apolipoprotein M as a new determinant of insulin sensitivity and relationship with adiponectin. Int J Obes (Lond). 2024 Jul;48(7):973-980. doi: 10.1038/s41366-024-01510-w. Epub 2024 Mar 15.
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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.
Sophie Beliard, MD contact
Urielle Desalbres study director
Assistance Publique Hôpitaux Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stable isotope enrichment methodology (5,5,5-D3-L-Leucine) in people with Obesity and Diabetes, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 4 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 17 Nov 2015. 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 France. 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 Sophie Beliard, MD (sophie.beliard@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
production and clearance rates of intestinal and hepatic TRL, in 2 groups of obese patients (15 patients per surgery procedure), before and 6 months after the surgery. (time frame: 7 months). 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 NCT02332434, 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 17 Nov 2015.