Effects of Gastric Bypass Surgery and Calcium Metabolism and the Skeleton

This study is currently recruiting participants.
Verified October 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: October 22, 2013
Last verified: October 2013

April 5, 2011
October 22, 2013
July 2011
January 2015   (final data collection date for primary outcome measure)
intestinal calcium absorption [ Time Frame: pre-operatively and 6 months post-operatively ] [ Designated as safety issue: No ]
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 (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 ]
  • 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
Group 1
Obese men and women undergoing gastric bypass surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
June 2016
January 2015   (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
No
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
United States
 
NCT01330914
ENDB-007-10F, 1IK2CX000549-01
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Anne L. Schafer, MD San Francisco VA Medical Center, San Francisco, CA
Department of Veterans Affairs
October 2013

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