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Effects of Gastric Bypass Surgery and Calcium Metabolism and the Skeleton

This study is currently recruiting participants.
Verified April 2013 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01330914
First received: April 5, 2011
Last updated: April 8, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition
Obesity, Morbid
Gastric Bypass

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Gastric Bypass Surgery on Calcium Metabolism and the Skeleton

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • intestinal calcium absorption [ Time Frame: pre-operatively and 6 months post-operatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • bone mineral density (areal and volumetric) [ Time Frame: pre-operatively and 6 and 12 months post-operatively ] [ Designated as safety issue: No ]
  • bone structure [ Time Frame: pre-operatively and 6 and 12 months post-operatively ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

serum, urine


Estimated Enrollment: 60
Study Start Date: July 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group 1
Obese men and women undergoing gastric bypass surgery

  Eligibility

Ages Eligible for Study:   25 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Men and women 25 to 70 years old scheduled to undergo gastric bypass surgery

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 <30 mL/min
  • Weight >350 pounds
  • Wrist circumference >12 inches or calf circumference >17 inches
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01330914

Contacts
Contact: Anne L Schafer, MD (415) 221-4810 ext 4895 Anne.Schafer@va.gov
Contact: Carl Grunfeld, MD PhD (415) 750-2005 Carl.Grunfeld@va.gov

Locations
United States, California
San Francisco VA Medical Center, San Francisco, CA Recruiting
San Francisco, California, United States, 94121
Contact: Anne L Schafer, MD     415-221-4810 ext 4895     Anne.Schafer@va.gov    
Contact: Carl Grunfeld, MD PhD     (415) 750-2005     Carl.Grunfeld@va.gov    
Principal Investigator: Anne L. Schafer, MD            
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Principal Investigator: Anne L. Schafer, MD San Francisco VA Medical Center, San Francisco, CA
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01330914     History of Changes
Other Study ID Numbers: ENDB-007-10F, 1IK2CX000549-01
Study First Received: April 5, 2011
Last Updated: April 8, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Obesity, Morbid
Bariatric Surgery
Gastric Bypass
Calcium Metabolism Disorders
 Vitamin D
Bone Density
Body Composition
Weight Loss

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013