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Effects of Gastric Bypass Surgery and Calcium Metabolism and the Skeleton

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01330914
First received: April 5, 2011
Last updated: April 12, 2016
Last verified: April 2016

April 5, 2011
April 12, 2016
July 2011
April 2014   (final data collection date for primary outcome measure)
Change in Intestinal Calcium Absorption [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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%.

intestinal calcium absorption [ Time Frame: pre-operatively (baseline) and 6 months post-operatively ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01330914 on ClinicalTrials.gov Archive Site
  • Bone Mineral Density (BMD, Areal and Volumetric) [ Time Frame: pre-operatively and 6 and 12 months post-operatively ] [ Designated as safety issue: No ]
    Areal BMD at the spine, proximal femur, and forearm by dual-energy X-ray absorptiometry (DXA); volumetric BMD at the spine and hip by quantitative computed tomography (QCT); volumetric BMD at the ultradistal radius and ultradistal tibia by high-resolution peripheral QCT (HR-pQCT)
  • Bone Structure [ Time Frame: pre-operatively and 6 and 12 months post-operatively ] [ Designated as safety issue: No ]
    Trabecular and cortical bone microstructure by HR-pQCT
  • bone mineral density (areal and volumetric) [ Time Frame: pre-operatively (baseline) and 6 and 12 months post-operatively ] [ Designated as safety issue: No ]
  • Bone Structure [ Time Frame: pre-operatively (baseline) and 6 and 12 months post-operatively ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effects of Gastric Bypass Surgery and Calcium Metabolism and the Skeleton
Effects of Gastric Bypass Surgery on Calcium Metabolism and the Skeleton
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
serum, urine
Non-Probability Sample
Men and women 25 to 70 years old scheduled to undergo gastric bypass surgery
  • Obesity, Morbid
  • Gastric Bypass
Not Provided
Gastric Bypass Surgery Patients
Obese men and women undergoing gastric bypass surgery

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
January 2015
April 2014   (final data collection date for primary outcome measure)

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 <30 mL/min
  • Weight >350 pounds
  • Wrist circumference >12 inches or calf circumference >17 inches
Both
25 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01330914
ENDB-007-10F, 1IK2CX000549-01
No
Not Provided
Not Provided
VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: Anne L Schafer, MD San Francisco VA Medical Center, San Francisco, CA
VA Office of Research and Development
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP