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Effects of Gastric Bypass Surgery and Calcium Metabolism and the Skeleton

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VA Office of Research and Development

Status

Completed

Conditions

Gastric Bypass
Obesity, Morbid

Study type

Observational

Funder types

Other U.S. Federal agency

Identifiers

NCT01330914
ENDB-007-10F
1IK2CX000549-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

55 patients

Sex

All

Ages

25 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

  • 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

Trial design

55 participants in 1 patient group

Gastric Bypass Surgery Patients
Description:
Obese men and women undergoing gastric bypass surgery

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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