Effects of Sleeve Gastrectomy on Calcium Metabolism and the Skeleton



Status:Recruiting
Conditions:Obesity Weight Loss, Endocrine
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:25 - 70
Updated:6/29/2018
Start Date:June 15, 2016
End Date:May 2021
Contact:Anne Schafer, MD
Email:anne.schafer@ucsf.edu
Phone:415-221-4810

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In this pre-post observational study, the investigators will enroll and follow a cohort of
about 50 adults undergoing sleeve gastrectomy surgery for weight loss. Pre-operatively and at
6 and 12 months post-operatively, the investigators will use state-of-the-art metabolic and
imaging techniques to evaluate calcium metabolism and skeletal health. Specific outcomes
include intestinal calcium absorption capacity, bone mineral density (BMD) assessed by
dual-energy X-ray absorptiometry (DXA) and quantitative computed tomography (QCT), and bone
structure assessed by QCT and high-resolution peripheral QCT (HR-pQCT).


Inclusion Criteria:

- Women and men 25 to 70 years old scheduled to undergo sleeve gastrectomy

Please note that the investigators are unable to provide sleeve gastrectomy; rather,
potential participants must already be planning the procedure with their surgeons.

Exclusion Criteria:

- Perimenopausal women, defined as last menses >3 months but < 5 years ago

- Known intestinal malabsorption (e.g., celiac disease, short gut syndrome, prior
intestinal surgery)

- Prior bariatric surgery

- Use of medications known to impact bone and mineral metabolism, including use of a
bisphosphonate or teriparatide in the last year or for >12 months ever; current
calcitonin; prednisone >5 mg daily or the equivalent glucocorticoid for >10 days in
the last 3 months; a current thiazolidinedione (TZD); an aromatase inhibitor; androgen
deprivation therapy; an antiepileptic agent known to alter hepatic vitamin D
clearance; or thyroid hormone replacement with current thyroid stimulating hormone <
0.1 milli-international units per liter

- Disease known to affect bone (e.g., primary hyperparathyroidism, Pagets disease,
clinically significant liver disease)

- Illicit drug use or alcohol use >3 drinks/day

- Serum calcium >10.2 mg/dL or calculated creatinine clearance < 30 mL/min

- Weight >350 pounds (the maximum weight limit of the QCT scanner) at the time of the
pre-operative QCT scan
We found this trial at
1
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1635 Divisadero Street
San Francisco, California 94143
Phone: 415-221-4810
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San Francisco, CA
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