Overview

This trial is active, not recruiting.

Conditions obesity, morbid, gastric bypass
Sponsor Department of Veterans Affairs
Start date July 2011
End date April 2014
Trial size 60 participants
Trial identifier NCT01330914, 1IK2CX000549-01, ENDB-007-10F

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Obese men and women undergoing gastric bypass surgery

Primary Outcomes

Measure
intestinal calcium absorption
time frame: pre-operatively and 6 months post-operatively

Secondary Outcomes

Measure
bone mineral density (areal and volumetric)
time frame: pre-operatively and 6 and 12 months post-operatively
bone structure
time frame: pre-operatively and 6 and 12 months post-operatively

Eligibility Criteria

Male or female participants from 25 years up to 70 years old.

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

Additional Information

Official title Effects of Gastric Bypass Surgery on Calcium Metabolism and the Skeleton
Principal investigator Anne L Schafer, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Department of Veterans Affairs.