Effects of Medical and Surgical Weight Loss on Metabolism (BOS)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by Garvan Institute of Medical Research.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Garvan Institute of Medical Research
Information provided by:
Garvan Institute of Medical Research
ClinicalTrials.gov Identifier:
NCT00592735
First received: January 1, 2008
Last updated: January 11, 2008
Last verified: January 2008
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 1, 2008 | ||||
| Last Updated Date | January 11, 2008 | ||||
| Start Date ICMJE | May 2007 | ||||
| Estimated Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
weight loss [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00592735 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effects of Medical and Surgical Weight Loss on Metabolism | ||||
| Official Title ICMJE | The Role of Adipocyte-Derived Inflammatory Cytokines in the Pathogenesis of Diabetes, Dyslipidaemia, Atherosclerosis and Gastro-Oesophageal Reflux Disease: the Effects of Medical and Surgical Weight Loss | ||||
| Brief Summary | This study will follow ,morbidly obese subjects as they undertake weight loss before and after laparoscopic gastric banding, examining markers of glucose and lipid metabolism, adipokines and measures of body fat. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: serum, tissue |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | morbidly obese subjects with type 2 diabetes or metabolic syndrome |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: laparoscopic gastric banding
standard surgical procedure |
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| Study Group/Cohort (s) | 1
Intervention: Procedure: laparoscopic gastric banding |
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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 | ||||
| Estimated Completion Date | December 2008 | ||||
| Estimated Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Australia | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00592735 | ||||
| Other Study ID Numbers ICMJE | SVH H06/151, SVH H06/151 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Katherine Samaras, Garvan Institute of Medical Research | ||||
| Study Sponsor ICMJE | Garvan Institute of Medical Research | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Garvan Institute of Medical Research | ||||
| Verification Date | January 2008 | ||||
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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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