- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01824797
Bone Metabolism After Bariatric Surgery
Determining Changes in Bone Metabolism After Bariatric Surgery in Postmenopausal Women
The purpose and objective of this study is to determine the changes in bone metabolism after bariatric surgery in postmenopausal women.
This is a prospective cohort study that will enroll up to 40 postmenopausal female subjects with class II and III obesity from the Duke Center for Metabolic and Weight Loss Surgery. The study team will enroll subjects that are already being scheduled for either sleeve gastrectomy or Roux-en-Y gastric bypass. The osteoclast activity, the osteoblast activity, and the bone mineral density will be measured in all subjects preoperatively and 12 months postoperatively through research specific blood tests and Dual energy x-ray Absorptiometry (DEXA) scans.
The primary endpoints are change in osteoclast activity as measured by C-terminal telopeptide of type I collagen and change in bone density as measured by DEXA scan. These are continuous variable and given the small sample size the investigators will use a nonparametric Wilcoxon rank-sum test to compare the difference in one year change in these variables. There is a slight risk of loss of confidentiality. Every effort will be made to protect all PHI. There is also the risk of increased exposure to radiation from the DEXA scans performed twice with each subjects participating in the study.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27704
- Duke Center for Metabolic and Weight Loss Surgery
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Postmenopausal women as determined by having a history of no menstrual bleed for greater than one year.
- Body Mass Index ≥35 kg/m² and stable weight for the previous 3 months.
- Able to speak and read English.
- Being scheduled for either Roux-en-Y gastric bypass or sleeve gastrectomy.
Exclusion Criteria:
- A documented history of osteoporosis or currently receiving medical treatment for osteoporosis with bisphosphonates, teriparatide, raloxifene, or denosumab.
- Weight greater than 295 pounds as this is the weight limit for our Dual-energy X-ray absorptiometry machine.
- Current or past (less than 1 year from enrollment) usage of estrogen hormone replacement therapy.
- Current smoker
- Any history of glucocorticoid use greater than one year in duration or current use of glucocorticoids.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Roux-en-Y Gastric Bypass
Changes in bone mineral density will be determined by comparing a peroperative DEXA scan with a one year postoperative DEXA scan on postmenopausal subjects who have already planned to undergo Roux-en-Y gastric bypass or sleeve gastrectomy.
Serum will be collected from subjects preoperatively and 12 months postoperatively.
The serum will be used at the completion of the study to run enzyme-linked immunosorbent assay (ELISA) to determine biochemical changes in bone metabolism.
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Sleeve Gastrectomy
Changes in bone mineral density will be determined by comparing a peroperative DEXA scan with a one year postoperative DEXA scan on postmenopausal subjects who have already planned to undergo Roux-en-Y gastric bypass or sleeve gastrectomy.
Serum will be collected from subjects preoperatively and 12 months postoperatively.
The serum will be used at the completion of the study to run enzyme-linked immunosorbent assay (ELISA) to determine biochemical changes in bone metabolism.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Bone Mineral Density
Time Frame: Baseline to one year postoperative
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Changes in bone mineral density will be determined by comparing a peroperative DEXA scan with a one year postoperative DEXA scan on postmenopausal subjects who have already planned to undergo Roux-en-Y gastric bypass or sleeve gastrectomy.
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Baseline to one year postoperative
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biochemical Changes in Bone Metabolism
Time Frame: Baseline to one year postoperative
|
Serum will be collected from the subjects preoperatively and 12 months postoperatively.
The serum will be used at the completion of the study to run enzyme-linked immunosorbent assay (ELISA) to determine biochemical changes in their bone metabolism.
|
Baseline to one year postoperative
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Daniel Guerron, MD, Duke University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00044248
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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