Bone Metabolism After Bariatric Surgery
Determining Changes in Bone Metabolism After Bariatric Surgery in Postmenopausal Women
Determining Changes in Bone Metabolism After Bariatric Surgery in Postmenopausal Women
Sponsor study identifier
observational
42
1 country
1
Study Start
May 2013
Actual (reported)Primary Completion
May 31, 2018
Actual (reported)Study Completion
May 31, 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 31, 2018
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2, 2013
Actual (reported)April 5, 2013
Actual (reported)May 2013
Actual (reported)May 31, 2018
Actual (reported)May 31, 2018
Actual (reported)Changes in Bone Mineral Density
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.
Baseline to one year postoperative
Biochemical Changes in Bone Metabolism
Baseline to one year postoperative
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.
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.
Postmenopausal females scheduled to undergo Roux-en-Y gastric bypass or Sleeve Gastrectomy.
Duke Center for Metabolic and Weight Loss Surgery
Durham, North Carolina, 27704, United States
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.
Daniel Guerron, MD
Duke University
42 participants (actual enrollment reported by the registry).
First Submitted
April 2, 2013
First Posted
April 5, 2013
Study Start
May 2013
Actual (reported)Primary Completion
New Media Obesity Treatment in Community Health Centers
Contact the study team to confirm eligibility.
May 31, 2018
Actual (reported)Study Completion
May 31, 2018
Actual (reported)Last Updated
August 16, 2019
Record last verified: 2019-08
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Source: ClinicalTrials.gov.
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