Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
42 participants
OBSERVATIONAL
2013-05-31
2018-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Body Mass Index ≥35 kg/m² and stable weight for the previous 3 months.
3. Able to speak and read English.
4. Being scheduled for either Roux-en-Y gastric bypass or sleeve gastrectomy.
Exclusion Criteria
2. Weight greater than 295 pounds as this is the weight limit for our Dual-energy X-ray absorptiometry machine.
3. Current or past (less than 1 year from enrollment) usage of estrogen hormone replacement therapy.
4. Current smoker
5. Any history of glucocorticoid use greater than one year in duration or current use of glucocorticoids.
40 Years
FEMALE
No
Sponsors
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Society of American Gastrointestinal and Endoscopic Surgeons
OTHER
Duke University
OTHER
Responsible Party
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Principal Investigators
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Daniel Guerron, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke Center for Metabolic and Weight Loss Surgery
Durham, North Carolina, United States
Countries
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Related Links
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Luhrs, A.R., Davalos, G., Lerebours, R. et al. Surg Endosc (2019)
Other Identifiers
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Pro00044248
Identifier Type: -
Identifier Source: org_study_id
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