Bone and Muscle Health Following Sleeve Gastrectomy in Men, Premenopausal and Postmenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Change in vBMD at the spine (L2-L3) and proximal femur
研究概览
简要总结
Background: Bariatric surgery is gaining in popularity. While it's health benefits are undisputed, the older malabsorptive bariatric procedures (Roux-in-Y gastric bypass - RYGB and biliopancreatic diversion - BPD) are associated with an increased risk of fractures and falls as early as 3-5 years after surgery. Sleeve gastrectomy - SG is now the most performed bariatric procedure. Although SG does not cause malabsorption, it is predicted to result in bone and muscle loss via weight loss and weight loss-independent mechanisms. Primary aim: to compare the changes in spine volumetric bone mineral density (vBMD) by quantitative computed tomography (QCT) and muscle mass at mid-femur by computed tomography (CT) at 3 years in the 3 groups of: 1) men; 2) premenopausal women; 3) postmenopausal women after SG versus their respective non-surgical peers who did not undergo SG in the 3-year period following recruitment. Secondary aims: to compare the changes in vBMD by QCT at skeletal sites other than the spine and in areal bone mineral density (aBMD) by dual-energy X-ray absorptiometry (DXA), whole-body muscle mass by DXA, muscle quality by CT at mid-femur and muscle strength as well as in selected physical performance and capacity tests shown to predict falls and fractures between 0-1 and 1-3 years after SG in the same 3 groups after SG vs. in the respective non-surgical groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged >18 years;
- •Awaiting SG for the bariatric group or meeting the criteria for SG but not undergoing surgery for the non-surgical group.
- •Menopause: defined as the absence of menses for a year and a serum follicular-stimulating hormone (FSH) >40 UI/L.
- •Women taking oral contraceptive pills or hormone replacement therapy
- •Patients with type 2 diabetes.
排除标准
- •Type 1 diabetes;
- •Disease (e.g., uncontrolled thyroid disease, Malabsorptive or overt inflammatory disorder)
- •Metabolic bone disease other than osteoporosis or type 2 diabetes,
- •Creatinine clearance <30 ml/min) or medication (e.g., glucocorticoids, anti-epileptic drugs, osteoporosis therapy, thiazolidinediones) affecting bone metabolism;
- •Weight >204 kg (DXA weight limit) or BMI >60 kg/m2 (upper limit to allow for QCT examination);
- •Current or planned pregnancy during follow-up; breast-feeding.
结局指标
主要结局
Change in vBMD at the spine (L2-L3) and proximal femur
时间窗: before, 1 year after and 3 years after bariatric surgery
assessed by QCT
Change in muscle mass at mid-femur
时间窗: before, 1 year after and 3 years after bariatric surgery
determined by measuring cross-sectional area at mid-femur (CT)
次要结局
- Change in aBMD at skeletal sites(before, 1 year after and 3 years after bariatric surgery)
- Change in muscle quality at mid-femur(before, 1 year after and 3 years after bariatric surgery)
- Change in vBMD at skeletal sites other than the spine(before, 1 year after and 3 years after bariatric surgery)
- Change in muscle strength(before, 1 year after and 3 years after bariatric surgery)
- Change in lower extremity muscle strength(before, 1 year after and 3 years after bariatric surgery)
- Change in whole body muscle mass(before, 1 year after and 3 years after bariatric surgery)
- Change in upper extremity muscle strength(before, 1 year after and 3 years after bariatric surgery)
- Change in muscle mass (muscle cross-sectional area) and function(before, 1 year after and 3 years after bariatric surgery)
研究者
Claudia Gagnon
Principal Investigator, Endocrinologist, Regular Researcher of the Endocrinology-Nephrology Axis
CHU de Quebec-Universite Laval