Effects of Gastric Bypass Surgery and Calcium Metabolism and the Skeleton
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|ClinicalTrials.gov Identifier: NCT01330914|
Recruitment Status : Completed
First Posted : April 7, 2011
Results First Posted : January 7, 2016
Last Update Posted : March 15, 2019
|Condition or disease|
|Obesity, Morbid Gastric Bypass|
|Study Type :||Observational|
|Actual Enrollment :||55 participants|
|Official Title:||Effects of Gastric Bypass Surgery on Calcium Metabolism and the Skeleton|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||January 2015|
Gastric Bypass Surgery Patients
Obese men and women undergoing gastric bypass surgery
- Change in Intestinal Calcium Absorption [ Time Frame: 6 months (between baseline and 6 months) ]
Change in fractional calcium absorption, determined by dual stable isotope method.
Fractional calcium absorption is the fraction of ingested calcium that is absorbed, which is expressed here as the percentage of ingested calcium that is absorbed. The 6-month change is the mean difference in percentage absorption between time points. For example, if fractional calcium absorption were to decrease from 30% preoperatively to 25% at the 6-month postoperative time point, the change in fractional calcium absorption would be -5%.
- Areal Bone Mineral Density (BMD) at the Femoral Neck [ Time Frame: 12 months post-operatively (between baseline and 12 months) ]Areal BMD at the femoral neck by dual-energy X-ray absorptiometry (DXA). The 12-month change is the percentage change between the 12 month and baseline time points.
- Trabecular Number at the Tibia [ Time Frame: 12 months post-operatively (between baseline and 12 months) ]Trabecular number at the tibia by high-resolution peripheral quantitative computed tomography (HR-pQCT). The 12-month change is the percentage change between the 12 month and baseline time points. HR-pQCT images were analyzed using the manufacturer's standard clinical evaluation protocol, with trabecular structure extracted using a threshold-based binarization process.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01330914
|United States, California|
|San Francisco VA Medical Center, San Francisco, CA|
|San Francisco, California, United States, 94121|
|Principal Investigator:||Anne L Schafer, MD||San Francisco VA Medical Center, San Francisco, CA|