Effects of Gastric Bypass Surgery and Calcium Metabolism and the Skeleton
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| First Received Date ICMJE | April 5, 2011 | ||||||||
| Last Updated Date | April 8, 2013 | ||||||||
| Start Date ICMJE | July 2011 | ||||||||
| Estimated Primary Completion Date | January 2015 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
intestinal calcium absorption [ Time Frame: pre-operatively and 6 months post-operatively ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
intestinal calcium absorption [ Time Frame: pre-operatively (baseline) and 6 months post-operatively ] [ Designated as safety issue: No ] | ||||||||
| Change History | Complete list of historical versions of study NCT01330914 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effects of Gastric Bypass Surgery and Calcium Metabolism and the Skeleton | ||||||||
| Official Title ICMJE | Effects of Gastric Bypass Surgery on Calcium Metabolism and the Skeleton | ||||||||
| Brief Summary | Obesity is a chronic illness of staggering proportions. Because weight loss through diet and exercise is difficult to attain and maintain, there has been escalating interest in bariatric surgery, including Roux-en-Y gastric bypass. Gastric bypass surgery results in long-term weight loss, dramatic improvement in comorbidities such as diabetes, and decreased mortality. Emerging evidence suggests, however, that gastric bypass may have negative effects on bone health. Because of the serious consequences of osteoporosis and fracture, this is of great concern. This study of the effects of gastric bypass on calcium metabolism and the skeleton may positively impact the clinical care of gastric bypass patients by their surgeons, primary care providers, and endocrinologists. Further, the knowledge gained may inform future investigation into the relationships between obesity, weight loss, and bone biology. |
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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 Without DNA Description: serum, urine |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Men and women 25 to 70 years old scheduled to undergo gastric bypass surgery |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Group 1
Obese men and women undergoing gastric bypass 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 | 60 | ||||||||
| Estimated Completion Date | June 2015 | ||||||||
| Estimated Primary Completion Date | January 2015 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Scheduled to undergo gastric bypass surgery. Please note that to be eligible, one must already be working with a bariatric surgeon and with plans in place to undergo gastric bypass. This study is unable to arrange or pay for gastric bypass surgery. Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 25 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01330914 | ||||||||
| Other Study ID Numbers ICMJE | ENDB-007-10F, 1IK2CX000549-01 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Department of Veterans Affairs | ||||||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Department of Veterans Affairs | ||||||||
| Verification Date | April 2013 | ||||||||
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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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