Impact of Bariatric Surgery on Epicardial Adipose Tissue and on Myocardial Function
| Tracking Information | |||||
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| First Received Date ICMJE | January 26, 2011 | ||||
| Last Updated Date | January 26, 2011 | ||||
| Start Date ICMJE | September 2010 | ||||
| Estimated Primary Completion Date | February 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The change in EAT amount 6 months after bariatric surgery. [ Time Frame: 36 months ] [ Designated as safety issue: No ] We thus investigated the effect of bariatric surgery on EAT in severely obese patients. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Evaluation of 3 parameters [ Time Frame: 36 months ] [ Designated as safety issue: No ]
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Impact of Bariatric Surgery on Epicardial Adipose Tissue and on Myocardial Function | ||||
| Official Title ICMJE | Impact of Bariatric Surgery on Epicardial Adipose Tissue and on Myocardial Function | ||||
| Brief 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. 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Intervention Model: Crossover Assignment Masking: Open Label |
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| Condition ICMJE | Severely Obese Patients | ||||
| Intervention ICMJE | Procedure: bariatric 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. |
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| Study Arm (s) | severely obese patients
20 patients addressed for severe obesity in the Endocrinology department of Marseille North Hospital before (V1) and 6 months (V2) after bariatric surgery
Intervention: Procedure: bariatric surgery |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 20 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | February 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01284816 | ||||
| Other Study ID Numbers ICMJE | 2010-A00696-33 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Assistance Publique des Hôpitaux de Marseille, Direction de la Recherche | ||||
| Study Sponsor ICMJE | Assistance Publique Hopitaux De Marseille | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Assistance Publique Hopitaux De Marseille | ||||
| Verification Date | January 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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