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N/A N=55

Effects of Gastric Bypass Surgery and Calcium Metabolism and the Skeleton

Obesity, Morbid · Gastric Bypass

Enrolled (actual)
55
Serious AEs
1.8%
Results posted
Jan 2016
Primary outcome: Primary: Change in Intestinal Calcium Absorption — -25.8 % of ingested calcium that is absorbed

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
Age
Adult, Older Adult · 25+ yrs
Sex
All
Sponsor
VA Office of Research and Development
Primary completion
Apr 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Intestinal Calcium Absorption
-25.8
SECONDARY
Areal Bone Mineral Density (BMD) at the Femoral Neck
-8.0
SECONDARY
Trabecular Number at the Tibia
-4.6

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.

Eligibility Criteria

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 350 pounds
  • Wrist circumference >12 inches or calf circumference >17 inches
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01330914). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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