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NCT01824797 · ClinicalTrials.gov registry record
Bone Metabolism After Bariatric Surgery
A clinical trial, sponsored by Duke University.
- Completed
- Registry status
- 42
- Enrollment target
NCT01824797: Completed study, sponsored by Duke University.
NCT01824797 is a clinical trial that has completed, run by Duke University. The registered enrollment target is 42 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01824797 has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- 42 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2013-05 |
| Est. Completion | 2018-05-31 |
What the finished NCT01824797 record still lists
NCT01824797 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 42 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01824797 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01824797 about?
NCT01824797 is a clinical study titled "Bone Metabolism After Bariatric Surgery". 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 We...
What is the current status of trial NCT01824797?
This trial is currently completed. The enrollment target is 42 participants. The study started on 2013-05. Estimated completion is 2018-05-31.
Who is sponsoring clinical trial NCT01824797?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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