Duke Center for Metabolic and Weight Loss Surgery
Durham, North Carolina, 27704, United States
NCT Number: NCT01824797
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.
Looking for future studies?
Notify Me40 year and older
Female
Observational
Durham, North Carolina, 27704, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
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.
Duke University
Other
Determining Changes in Bone Metabolism After Bariatric Surgery in Postmenopausal Women
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04093856
Body Weight, Bone Diseases
Montreal, Quebec, Canada
View Trial DetailsNCT04288401
Atrophy, Body Weight
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT03344718
Atrophy, Avitaminosis
Tainan, Taiwan
View Trial DetailsNCT04301427
Body Weight, Bone Diseases
Reims, France
View Trial Details