N/A
N=55
Effects of Gastric Bypass Surgery and Calcium Metabolism and the Skeleton
Obesity, Morbid · Gastric Bypass
Bottom Line
View on ClinicalTrials.gov: NCT01330914 ↗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
| Outcome | Result | p-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
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.