Effects of Gastric Bypass Surgery and Calcium Metabolism and the Skeleton

Completed

Conditions studied: Obesity, Morbid, Gastric Bypass

In brief

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.

Key facts

Study ID

NCT01330914

Run by

VA Office of Research and Development

People needed

55

Starts

2011-07-01

Expected to finish

2015-01-01

Last updated by the study team

2019-03-15

Who can join

Age: 25 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• San Francisco VA Medical Center, San Francisco, CA — San Francisco, California, United States

Full record on ClinicalTrials.gov

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