Bone Loss After Laparoscopic Roux-en-Y Gastric Bypass
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| First Received Date ICMJE | September 10, 2009 | ||||||||
| Last Updated Date | December 30, 2009 | ||||||||
| Start Date ICMJE | April 2007 | ||||||||
| Primary Completion Date | November 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Evaluate bone densitometry and lab tests to assess changes in bone mass and bone turnover after laparoscopic gastric bypass surgery [ Time Frame: preoperatively and at 6 and 12 months after laparoscopic Roux-en-Y gastric bypass ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00975013 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Evaluate weight loss, menopausal and nutritional status to assess correlations with results from bone densitometry and lab values after laparoscopic gastric bypass surgery [ Time Frame: preoperatively, and at 6 and 12 months after laparoscopic Roux-en-Y gastric bypass ] [ Designated as safety issue: No ] | ||||||||
| 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 | Bone Loss After Laparoscopic Roux-en-Y Gastric Bypass | ||||||||
| Official Title ICMJE | Losing More Than Just Weight: Bone Loss After Laparoscopic Roux-en-Y Gastric Bypass | ||||||||
| Brief Summary | The objective of this study is to assess changes bone mineral density and bone metabolism after laparoscopic Roux-en-Y gastric bypass surgery. The investigators hypothesize that weight loss after laparoscopic Roux-en-Y gastric bypass surgery will be associated with increased bone turnover, changes in bone metabolism, and loss of bone mass. |
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| Detailed Description | Obesity is an increasing problem within the United States. Fifteen million people in the United States are considered morbidly obese, with a body mass index (BMI) greater than 40 kg/m2. A wealth of literature has shown laparoscopic Roux-en Y gastric bypass surgery to be an effective procedure to reduce excess body weight. But a paucity of research examines the effects of laparoscopic Roux-en Y surgery on the skeleton. Bone remodeling is a complex process involving bone resorption and formation-a process dependent upon local and systemic influences. Obesity is one of these influences that is poorly understood. Obesity is associated with a reduced risk of osteoporosis. Obesity may be protective due to increased weight bearing, increased production of estrogen by adipose tissue, or increased bone formation due to higher levels of insulin. It is known that weight loss in healthy individuals is associated with bone loss. Several small studies have reported bone loss in patients undergoing vertical band gastroplasty or jejunoileal bypass weight loss surgeries. Other reported metabolic disease disarrangements following weight loss surgery are decreased serum calcium, decreased serum 25-hydroxy vitamin D, and hyperparathyroidism. In the bariatric literature, weight loss has been associated with an increased risk of bone mineral loss and fracture. Osteoporosis has been described in patients who lost weight after jejunoileal bypass surgery. Premenopausal women appeared to be spared from bone mineral loss, thus indicating a protective effect from the premenopausal state. Bone mineral loss is seen both in premenopausal women and in men after weight loss surgery. Roux-en Y gastric bypass has been shown to be more effective at weight loss than has the adjustable silicone gastric band. It has also been linked with increased loss of bone mineral density. Another study found an increase in bone turnover as well as a decrease in total bone mass and trochanteric bone density in laparoscopic Roux-en Y gastric bypass patients. Previous research at our institution has shown a statistically significant increase in the prevalence of hyperparathyroidism in post-gastric bypass patients. However, our previous research did not examine the impact that these hormonal changes impart upon bone density. We have found a statistically significant incidence of vitamin D deficiency in our patients following this surgery. We intend to expand upon our own research as well as that of others by exploring the associations between the development of hyperparathyroidism, bone metabolic derangements, weight loss, and bone density. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: whole blood |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Study population will consist of patients undergoing laparoscopic gastric bypass at a community-based teaching institution |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Bone Density Study Group
Morbidly obese, (BMI >40 kg/m2, or 35 kg/m2 with comorbidities) female patients who have given consent to undergo additional testing including bone densitometry, and lab testing preoperatively and at 6 and 12 months after undergoing elective laparoscopic roux-en-Y gastric bypass. |
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| Publications * |
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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 | Completed | ||||||||
| Enrollment ICMJE | 40 | ||||||||
| Completion Date | December 2009 | ||||||||
| Primary Completion Date | November 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 30 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00975013 | ||||||||
| Other Study ID Numbers ICMJE | 2-07-02-009 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Shanu N. Kothari, MD, Gundersen Lutheran Health System | ||||||||
| Study Sponsor ICMJE | Gundersen Lutheran Medical Foundation | ||||||||
| Collaborators ICMJE | Gundersen Lutheran Health System | ||||||||
| Investigators ICMJE |
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| Information Provided By | Gundersen Lutheran Medical Foundation | ||||||||
| Verification Date | December 2009 | ||||||||
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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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