Effects of Gastric Bypass Surgery on Calcium Metabolism and the Skeleton
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Change in Intestinal Calcium Absorption
研究概览
简要总结
Obesity is a chronic illness of staggering proportions. Because weight loss through diet and exercise is difficult to attain and maintain, there has been escalating interest in bariatric surgery, including Roux-en-Y gastric bypass. Gastric bypass surgery results in long-term weight loss, dramatic improvement in comorbidities such as diabetes, and decreased mortality. Emerging evidence suggests, however, that gastric bypass may have negative effects on bone health. Because of the serious consequences of osteoporosis and fracture, this is of great concern. This study of the effects of gastric bypass on calcium metabolism and the skeleton may positively impact the clinical care of gastric bypass patients by their surgeons, primary care providers, and endocrinologists. Further, the knowledge gained may inform future investigation into the relationships between obesity, weight loss, and bone biology.
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
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled to undergo gastric bypass surgery. Please note that to be eligible, one must already be working with a bariatric surgeon and with plans in place to undergo gastric bypass. This study is unable to arrange or pay for gastric bypass surgery.
排除标准
- •Perimenopausal women
- •Known intestinal malabsorption
- •Prior bariatric surgery
- •Use of medications known to impact bone and mineral metabolism
- •Disease known to affect bone
- •Illicit drug use or alcohol use >3 drinks/day
- •Serum calcium >10.2 mg/dL
- •Calculated creatinine clearance <30 mL/min
- •Weight >350 pounds
- •Wrist circumference >12 inches or calf circumference >17 inches
结局指标
主要结局
Change in Intestinal Calcium Absorption
时间窗: 6 months (between baseline and 6 months)
Change in fractional calcium absorption, determined by dual stable isotope method. Fractional calcium absorption is the fraction of ingested calcium that is absorbed, which is expressed here as the percentage of ingested calcium that is absorbed. The 6-month change is the mean difference in percentage absorption between time points. For example, if fractional calcium absorption were to decrease from 30% preoperatively to 25% at the 6-month postoperative time point, the change in fractional calcium absorption would be -5%.
次要结局
- Areal Bone Mineral Density (BMD) at the Femoral Neck(12 months post-operatively (between baseline and 12 months))
- Trabecular Number at the Tibia(12 months post-operatively (between baseline and 12 months))