Obese PatientsNCT01277068
Effects of Various Bariatric Surgical Procedures on Intestinal Triglyceride-rich-lipoprotein (TRL) Metabolism in Obese Patients
A study testing Surgical and medical procedures in people with Obese Patients and Production Rates of These TRL Before and After the Bariatric Surgery, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
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. An excess of TRL particles is one of the characteristics, represents a major cardiovascular risk factor. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obese Patients, Production Rates of These TRL Before and After the Bariatric Surgery, Cardiovascular Diseases
- What is being tested?
- Surgical and medical procedures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2010to Sep 2014
- 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
- Men or women from 18 to 65 years old
- Subject having a BMI included between 35 and 40 kg / m2 associated to at least a comorbidity susceptible to be improved after the surgery
- Subject in failure of a medical treatment, led by an expert in nutrition, associating a dietary coverage and a physical activity adapted for at least 6 months
- Subject without contraindication for 3 studied surgical techniques
- Subject without cardiovascular events 6 months ago
- subject is informed and is consented
- Subject having a biologic balance dating less than 3 months
Who cannot join
- subject with contraindication for 3 studied surgical techniques
- women pregnant
- subject did not consent and is not informed
Trial locations and contacts
1 site in 1 country.
About this study
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. An excess of TRL particles is one of the characteristics, represents a major cardiovascular risk factor. The overproduction of the intestinal TRL (which apoprotein B48 is the specific tracer) is recently recognized of insulin-resistance and the atherogenous role of these intestinal TRL has been shown. In front of this important overmortality, the bariatric surgery quickly developed. Three main procedures are performed: 2 based exclusively on the gastric restriction (the adjustable gastric banding and the sleeve gastrectomy) and one associating a malabsorption (the gastric bypass).
Read the detailed description
It is a monocentric, prospective, comparative study. After identification of the eligible subjects, the kinetics (production and clearance rates) of the intestinal TRL will be performed in the hospital, using a stable isotope method (5,5,5-D3-L-Leucine), in 3 groups of obese patients (12 patients per surgery procedure), before and 6 months after the surgery
- Conditions
- Obese Patients, Production Rates of These TRL Before and After the Bariatric Surgery, Cardiovascular Diseases
- Being tested
- Surgical and medical procedures
- Keywords
- obese patients, TRL, the bariatric surgery
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical and medical proceduresProcedure or surgery
this study want to compare the differential effect of the 3 bariatric surgery procedures on the production rates of the intestinal TRL: the adjustable gastric banding the sleeve gastrectomy the gastric bypass
| Study group | Role | What they receive |
|---|---|---|
| the adjustable gastric banding | Active comparator | Not described Receives: Procedure: Surgical and medical procedures |
| the sleeve gastrectomy | Active comparator | Not described Receives: Procedure: Surgical and medical procedures |
| the gastric bypass | Active comparator | Not described Receives: Procedure: Surgical and medical procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
to compare the differential effect of the 3 bariatric surgery procedures on the production rates of the intestinal TRL
the 3 bariatric surgery procedures are: the adjustable gastric banding the sleeve gastrectomy the gastric bypass (associating a malabsorption).
Measured: 36 months
Secondary outcomes (1)
to compare the production rates of these TRL before and after the bariatric surgery
TRL particles is one of the characteristics, represents a major cardiovascular risk factor. The overproduction of the 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
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2011 (estimated)
- Study startSep 2010
- Primary completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obese PatientsStudies 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- René Valero, Professor, Principal investigator, APHM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01277068
- Sponsor's protocol ID
- 2010-A00844-35
- Status last verified
- Aug 2015
- First submitted
- 13 Jan 2011
- Last updated
- 24 Aug 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 38491190Padilla N, Maraninchi M, Beliard S, Berthet B, Nogueira JP, Wolff E, Nicolay A, Begu A, Dubois N, Grangeot R, Mattei C, Vialettes B, Xiao C, Lewis GF, Valero R. Effects of bariatric surgery on hepatic and intestinal lipoprotein particle metabolism in obese, nondiabetic humans. Arterioscler Thromb Vasc Biol. 2014 Oct;34(10):2330-7. doi: 10.1161/ATVBAHA.114.303849. Epub 2014 Aug 7.
PubMed 25104797
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 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 Patients
- ClinicalTrials.gov ID
- NCT01277068
- Acronym / sponsor ID
- 2010-A00844-35
- Conditions
- Obese Patients, Production Rates of These TRL Before and After the Bariatric Surgery, Cardiovascular Diseases
- Keywords
- obese patients, TRL, the bariatric surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2014 (actual)
- First posted
- 14 Jan 2011 (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.
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. An excess of TRL particles is one of the characteristics, represents a major cardiovascular risk factor. The overproduction of the intestinal TRL (which apoprotein B48 is the specific tracer) is recently recognized of insulin-resistance and the atherogenous role of these intestinal TRL has been shown. In front of this important overmortality, the bariatric surgery quickly developed. Three main procedures are performed: 2 based exclusively on the gastric restriction (the adjustable gastric banding and the sleeve gastrectomy) and one associating a malabsorption (the gastric bypass).
Detailed description
It is a monocentric, prospective, comparative study. After identification of the eligible subjects, the kinetics (production and clearance rates) of the intestinal TRL will be performed in the hospital, using a stable isotope method (5,5,5-D3-L-Leucine), in 3 groups of obese patients (12 patients per surgery procedure), before and 6 months after the surgery
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| the adjustable gastric banding | Active comparator | Procedure: Surgical and medical procedures |
| the sleeve gastrectomy | Active comparator | Procedure: Surgical and medical procedures |
| the gastric bypass | Active comparator | Procedure: Surgical and medical procedures |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men or women from 18 to 65 years old
- Subject having a BMI included between 35 and 40 kg / m2 associated to at least a comorbidity susceptible to be improved after the surgery
- Subject in failure of a medical treatment, led by an expert in nutrition, associating a dietary coverage and a physical activity adapted for at least 6 months
- Subject without contraindication for 3 studied surgical techniques
- Subject without cardiovascular events 6 months ago
Key exclusion criteria (3 listed)
- subject with contraindication for 3 studied surgical techniques
- women pregnant
- subject did not consent and is not informed
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 |
|---|---|---|
| Surgical and medical proceduresthis study want to compare the differential effect of the 3 bariatric surgery procedures on the production rates of the intestinal TRL: the adjustable gastric banding the sleeve gastrectomy the gastric bypass | Procedure or surgery | the adjustable gastric banding, the gastric bypass, the sleeve gastrectomy |
Primary outcome
to compare the differential effect of the 3 bariatric surgery procedures on the production rates of the intestinal TRL
Time frame: 36 months
the 3 bariatric surgery procedures are: the adjustable gastric banding the sleeve gastrectomy the gastric bypass (associating a malabsorption).
1 secondary outcome
to compare the production rates of these TRL before and after the bariatric surgery
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 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.
- Derived from this study: PubMed 25104797Padilla N, Maraninchi M, Beliard S, Berthet B, Nogueira JP, Wolff E, Nicolay A, Begu A, Dubois N, Grangeot R, Mattei C, Vialettes B, Xiao C, Lewis GF, Valero R. Effects of bariatric surgery on hepatic and intestinal lipoprotein particle metabolism in obese, nondiabetic humans. Arterioscler Thromb Vasc Biol. 2014 Oct;34(10):2330-7. doi: 10.1161/ATVBAHA.114.303849. Epub 2014 Aug 7.
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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.
René Valero, Professor principal investigator
APHM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical and medical procedures in people with Obese Patients and Production Rates of These TRL Before and After the Bariatric Surgery, 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 7 inclusion and 3 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: finished, as of the sponsor's last update on 24 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to compare the differential effect of the 3 bariatric surgery procedures on the production rates of the intestinal TRL (time frame: 36 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 NCT01277068, which also lists 2 linked publications.
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 24 Aug 2015.