Severely Obese PatientsNCT01284816
Impact of Bariatric Surgery on Epicardial Adipose Tissue and on Myocardial Function
A study testing bariatric surgery in people with Severely Obese Patients, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Growing evidence suggests that bariatric surgery is a relevant treatment for severely obese patients, especially those with metabolic complications, as it significantly reduces weight, hypertension and ameliorates glycemic control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severely Obese Patients
- What is being tested?
- bariatric surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2010to Jul 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men or women who have more than 18 years
- patients have been informed and have consented
- severely obese patients with surgery indication
Who cannot join
- contraindications at surgery, at MNR imagery
- History of infarct, of congenital cardiomyopathy
- Treatment modifying the distribution of the fat
- Pregnant or breast-feeding women
- patients less than 18 years
- Patient without consentment
Trial locations and contacts
1 site in 1 country.
About this study
Growing evidence suggests that bariatric surgery is a relevant treatment for severely obese patients, especially those with metabolic complications, as it significantly reduces weight, hypertension and ameliorates glycemic control. Its action on adipose tissue distribution and in particular on epicardial adipose tissue EAT remains unknown. Whether metabolic improvement is associated with EAT reduction is also unknown.
The researchers thus investigated the effect of bariatric surgery on EAT in severely obese patients. The primary endpoint of this study was the change in EAT amount 6 months after bariatric surgery.
Read the detailed description
The best of our knowledge, no study has really addressed whether this EAT was modulated by diet or therapeutics like bariatric surgery. The researchers were particularly interested in studying the impact of bariatric surgery and of weight loss on the amount of EAT and whether reduction in EAT could have a positive impact on myocardial function.
- Conditions
- Severely Obese Patients
- Being tested
- bariatric surgery
- Keywords
- severely obese patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bariatric surgeryProcedure or surgery
The bariatric surgery is a relevant treatment for severely obese patients those with metabolic complications, as it significantly reduces weight, hypertension and ameliorates glycemic control.
| Study group | Role | What they receive |
|---|---|---|
| severely obese patients | Other | 35 patients addressed for severe obesity in the Endocrinology department of Marseille North Hospital before (V1) and 6 months (V2) after bariatric surgery Receives: Procedure: bariatric surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in EAT amount 6 months after bariatric surgery.
We thus investigated the effect of bariatric surgery on EAT in severely obese patients.
Measured: 36 months
Secondary outcomes (1)
Evaluation of 3 parameters
- to evaluate the variation in myocardial, hepatic , pancreatic and triglyceride content
- to evaluate the variation in left ventricular function or myocardial function
- and to describe the relationships between changes in visceral abdominal fat, subcutaneous fat and epicardial fat
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 posted27 Jan 2011 (estimated)
- Study startSep 2010
- Primary completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Severely 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
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Dutour, Professor, Principal investigator, AP-HM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01284816
- Sponsor's protocol ID
- 2010-A00696-33
- Status last verified
- Jul 2015
- First submitted
- 26 Jan 2011
- Last updated
- 24 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Soghomonian A, Dutour A, Kachenoura N, Thuny F, Lasbleiz A, Ancel P, Cristofari R, Jouve E, Simeoni U, Kober F, Bernard M, Gaborit B. Is increased myocardial triglyceride content associated with early changes in left ventricular function? A 1H-MRS and MRI strain study. Front Endocrinol (Lausanne). 2023 Jun 22;14:1181452. doi: 10.3389/fendo.2023.1181452. eCollection 2023.
PubMed 37424866Henry JA, Abdesselam I, Deal O, Lewis AJ, Rayner J, Bernard M, Dutour A, Gaborit B, Kober F, Soghomonian A, Sgromo B, Byrne J, Bege T, Neubauer S, Borlaug BA, Rider OJ. Changes in epicardial and visceral adipose tissue depots following bariatric surgery and their effect on cardiac geometry. Front Endocrinol (Lausanne). 2023 Jan 25;14:1092777. doi: 10.3389/fendo.2023.1092777. eCollection 2023.
PubMed 36761185Gaborit B, Jacquier A, Kober F, Abdesselam I, Cuisset T, Boullu-Ciocca S, Emungania O, Alessi MC, Clement K, Bernard M, Dutour A. Effects of bariatric surgery on cardiac ectopic fat: lesser decrease in epicardial fat compared to visceral fat loss and no change in myocardial triglyceride content. J Am Coll Cardiol. 2012 Oct 9;60(15):1381-9. doi: 10.1016/j.jacc.2012.06.016. Epub 2012 Aug 29.
PubMed 22939560
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Bariatric Surgery on Epicardial Adipose Tissue and on Myocardial Function
- ClinicalTrials.gov ID
- NCT01284816
- Acronym / sponsor ID
- 2010-A00696-33
- Conditions
- Severely Obese Patients
- Keywords
- severely obese patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jul 2015 (actual)
- First posted
- 27 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.
Growing evidence suggests that bariatric surgery is a relevant treatment for severely obese patients, especially those with metabolic complications, as it significantly reduces weight, hypertension and ameliorates glycemic control. Its action on adipose tissue distribution and in particular on epicardial adipose tissue EAT remains unknown. Whether metabolic improvement is associated with EAT reduction is also unknown.
The researchers thus investigated the effect of bariatric surgery on EAT in severely obese patients. The primary endpoint of this study was the change in EAT amount 6 months after bariatric surgery.
Detailed description
The best of our knowledge, no study has really addressed whether this EAT was modulated by diet or therapeutics like bariatric surgery. The researchers were particularly interested in studying the impact of bariatric surgery and of weight loss on the amount of EAT and whether reduction in EAT could have a positive impact on myocardial function.
Study design
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| severely obese patients | Other | Procedure: bariatric surgery35 patients addressed for severe obesity in the Endocrinology department of Marseille North Hospital before (V1) and 6 months (V2) after bariatric surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- men or women who have more than 18 years
- patients have been informed and have consented
- severely obese patients with surgery indication
Key exclusion criteria (6 listed)
- contraindications at surgery, at MNR imagery
- History of infarct, of congenital cardiomyopathy
- Treatment modifying the distribution of the fat
- Pregnant or breast-feeding women
- patients less than 18 years
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 |
|---|---|---|
| bariatric surgeryThe bariatric surgery is a relevant treatment for severely obese patients those with metabolic complications, as it significantly reduces weight, hypertension and ameliorates glycemic control. | Procedure or surgery | severely obese patients |
Primary outcome
The change in EAT amount 6 months after bariatric surgery.
Time frame: 36 months
We thus investigated the effect of bariatric surgery on EAT in severely obese patients.
1 secondary outcome
Evaluation of 3 parameters
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 Jul 2015.
- Derived from this study: PubMed 37424866Soghomonian A, Dutour A, Kachenoura N, Thuny F, Lasbleiz A, Ancel P, Cristofari R, Jouve E, Simeoni U, Kober F, Bernard M, Gaborit B. Is increased myocardial triglyceride content associated with early changes in left ventricular function? A 1H-MRS and MRI strain study. Front Endocrinol (Lausanne). 2023 Jun 22;14:1181452. doi: 10.3389/fendo.2023.1181452. eCollection 2023.
- Derived from this study: PubMed 36761185Henry JA, Abdesselam I, Deal O, Lewis AJ, Rayner J, Bernard M, Dutour A, Gaborit B, Kober F, Soghomonian A, Sgromo B, Byrne J, Bege T, Neubauer S, Borlaug BA, Rider OJ. Changes in epicardial and visceral adipose tissue depots following bariatric surgery and their effect on cardiac geometry. Front Endocrinol (Lausanne). 2023 Jan 25;14:1092777. doi: 10.3389/fendo.2023.1092777. eCollection 2023.
- Derived from this study: PubMed 22939560Gaborit B, Jacquier A, Kober F, Abdesselam I, Cuisset T, Boullu-Ciocca S, Emungania O, Alessi MC, Clement K, Bernard M, Dutour A. Effects of bariatric surgery on cardiac ectopic fat: lesser decrease in epicardial fat compared to visceral fat loss and no change in myocardial triglyceride content. J Am Coll Cardiol. 2012 Oct 9;60(15):1381-9. doi: 10.1016/j.jacc.2012.06.016. Epub 2012 Aug 29.
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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.
Anne Dutour, Professor principal investigator
AP-HM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bariatric surgery in people with Severely Obese Patients, 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 3 inclusion and 6 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 Jul 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?
The change in EAT amount 6 months after bariatric surgery. (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 NCT01284816, which also lists 3 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 Jul 2015.