Bone Metabolism After Bariatric Surgery

Sponsor

Duke University (Other)

Overall Status

Completed

CT.gov ID

NCT01824797

Collaborator

Society of American Gastrointestinal and Endoscopic Surgeons (Other)

Enrollment

Location

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Osteoporosis

Study Design

Study Type:

Observational

Actual Enrollment :

42 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Determining Changes in Bone Metabolism After Bariatric Surgery in Postmenopausal Women

Actual Study Start Date :

May 1, 2013

Actual Primary Completion Date :

May 31, 2018

Actual Study Completion Date :

May 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
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.
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.

Arm

Intervention/Treatment

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.

Sleeve Gastrectomy

Outcome Measures

Primary Outcome Measures

Changes in Bone Mineral Density [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.

Secondary Outcome Measures

Biochemical Changes in Bone Metabolism [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.