- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01824797
Bone Metabolism After Bariatric Surgery
Determining Changes in Bone Metabolism After Bariatric Surgery in Postmenopausal Women
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.
연구 개요
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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North Carolina
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Durham, North Carolina, 미국, 27704
- Duke Center for Metabolic and Weight Loss Surgery
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes in Bone Mineral Density
기간: Baseline to one year postoperative
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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.
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Baseline to one year postoperative
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Biochemical Changes in Bone Metabolism
기간: Baseline to one year postoperative
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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.
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Baseline to one year postoperative
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Daniel Guerron, MD, Duke University
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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