- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02778490
Effects of Sleeve Gastrectomy on Calcium Metabolism and the Skeleton
Study Overview
Status
Conditions
Detailed Description
Obesity is a chronic disease of staggering proportions. Because weight loss through diet and exercise is difficult to attain and maintain, there is escalating interest in surgical weight loss procedures, including Roux-en-Y gastric bypass. Gastric bypass results in marked and durable weight loss and improvement in comorbidities in the general population and in our veteran patients. However, growing evidence indicates that gastric bypass can have negative effects on the skeleton, increasing bone turnover and decreasing bone mineral density (BMD). This is of critical concern given the tremendous impact of osteoporosis and fracture in both men and women. Vitamin D deficiency due to obesity and post-surgical malabsorption may partially explain the decline in bone mass observed after gastric bypass. Other factors are likely involved as well, such as non-vitamin D-mediated calcium malabsorption, signals related to decreased skeletal loading, and changes in fat-secreted hormones or estrogen (due to changes in fat mass and body composition).
We will characterize the effects of gastric bypass on calcium metabolism and the skeleton in a cohort of 80 men and women whose serum 25-hydroxyvitamin D levels are supplemented and maintained at ≥30 ng/mL. First, we will test the hypothesis that intestinal calcium absorption is impaired following gastric bypass, even in the setting of vitamin D sufficiency. We will do this by measuring fractional calcium absorption pre-operatively and 6 months post-operatively using dual stable isotopic tracers (Aim 1). Then, we will test the hypothesis that gastric bypass results in decreased BMD and in structural changes associated with impaired skeletal strength. We will do this by performing dual-energy X-ray absorptiometry (DXA), quantitative computed tomography (QCT), and high-resolution peripheral QCT (HR-pQCT) pre-operatively and 6 and 12 months post-operatively (Aim 2). QCT and HR-pQCT are advanced imaging techniques that have distinct advantages over standard methods but have not yet been applied to this population. Finally, we will assess body composition changes by anthropometry, DXA, and QCT, and changes in fat-secreted hormones, and we will evaluate the relationship between changes in skeletal parameters and changes in body composition and hormones (Aim 3). This research is expected to impact the clinical care of gastric bypass patients by helping to shape recommendations about post-operative nutrition, BMD screening, and potential therapy.
As an ancillary study aim (Aim 4), we will assess vertebral bone marrow fat pre- and post-operatively in a subgroup of participants, and we will evaluate the relationships between change in vertebral bone marrow fat, changes in body composition and fat-secreted hormones, and changes in skeletal parameters. The participants in this subgroup will have the option of undergoing additional knee tissue composition evaluation, allowing us to evaluate the relationship between weight loss and change in knee health. In order to develop and refine the magnetic resonance (MR) sequences we will use for Aim 4, we will scan a small group of healthy controls at baseline and after 6 months.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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San Francisco, California, United States, 94143
- UCSF
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in intestinal fractional calcium absorption
Time Frame: 6 months
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The investigators will determine whether there is a change in intestinal calcium absorption, assessed using the dual stable isotopes Ca-43 and Ca-44 in the setting of robust vitamin D status, following sleeve gastrectomy.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage change in spinal volumetric bone mineral density
Time Frame: 12 months
|
The investigators will define the effects of sleeve gastrectomy on spinal volumetric bone mineral density, assessed by quantitative computed tomography (QCT).
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12 months
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Percentage change in volumetric bone mineral density at the distal tibia
Time Frame: 12 months
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The investigators will define the effects of sleeve gastrectomy on total volumetric bone mineral density at the distal tibia, assessed by high-resolution peripheral quantitative computed tomography (HR-pQCT).
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12 months
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Percentage change in cortical porosity at the distal tibia
Time Frame: 12 months
|
The investigators will define the effects of sleeve gastrectomy on cortical porosity at the distal tibia, assessed by high-resolution peripheral quantitative computed tomography (HR-pQCT).
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12 months
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage change in spinal volumetric bone mineral density by QCT
Time Frame: 6 months
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6 months
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Percentage change in volumetric bone mineral density at the distal tibia by HR-pQCT
Time Frame: 6 months
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6 months
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Percentage change in cortical porosity at the distal tibia by HR-pQCT
Time Frame: 6 months
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6 months
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Percentage changes in cortical and trabecular volumetric bone mineral density and microstructural parameters at the radius and tibia by HR-pQCT
Time Frame: 6 months and 12 months
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6 months and 12 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Anne Schafer, MD, San Francisco VA Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01DK107629 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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