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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
Results First Received: December 2, 2015  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Obesity, Morbid
Gastric Bypass

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Women and men 25-70 years of age were recruited from two academic bariatric surgery centers (the University of California, San Francisco and the San Francisco Veterans Affairs Medical Center), where surgeons used the same standardized surgical approach to Roux-en-Y gastric bypass.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Gastric Bypass Surgery Patients Obese men and women undergoing gastric bypass surgery

Participant Flow:   Overall Study
    Gastric Bypass Surgery Patients
STARTED   55 
COMPLETED   48 
NOT COMPLETED   7 
Withdrawal by Subject                4 
No longer eligible (sleeve gastrectomy)                3 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Gastric Bypass Surgery Patients Obese men and women undergoing gastric bypass surgery

Baseline Measures
   Gastric Bypass Surgery Patients 
Overall Participants Analyzed 
[Units: Participants]
 55 
Age 
[Units: Years]
Mean (Standard Deviation)
 45.8  (11.2) 
Gender 
[Units: Participants]
 
Female   44 
Male   11 
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   6 
Not Hispanic or Latino   49 
Unknown or Not Reported   0 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   1 
Asian   3 
Native Hawaiian or Other Pacific Islander   2 
Black or African American   12 
White   37 
More than one race   0 
Unknown or Not Reported   0 
Region of Enrollment 
[Units: Participants]
 
United States   55 
Menopausal status 
[Units: Participants]
 
Premenopausal   30 
Postmenopausal   14 
N/A (Men)   11 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 122.7  (19.3) 
Body mass index 
[Units: Kg/m2]
Mean (Standard Deviation)
 44.2  (7.0) 
Percentage body fat 
[Units: Percentage of body fat]
Mean (Standard Deviation)
 46.7  (5.9) 
Diabetes status 
[Units: Participants]
 
Diabetic   22 
Not diabetic   33 
Femoral neck areal bone mineral density (DXA) 
[Units: G/cm2]
Mean (Standard Deviation)
 0.949  (0.133) 
Spine volumetric bone mineral density (QCT) 
[Units: G/cm3]
Mean (Standard Deviation)
 0.159  (0.036) 


  Outcome Measures

1.  Primary:   Change in Intestinal Calcium Absorption   [ Time Frame: 6 months ]

2.  Secondary:   Bone Mineral Density (BMD, Areal and Volumetric)   [ Time Frame: pre-operatively and 6 and 12 months post-operatively ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Bone Structure   [ Time Frame: pre-operatively and 6 and 12 months post-operatively ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Anne Schafer
Organization: San Francisco Veterans Affairs Medical Center
phone: (415) 221-4810 ext 24895
e-mail: anne.schafer@va.gov


Publications of Results:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01330914     History of Changes
Other Study ID Numbers: ENDB-007-10F
1IK2CX000549-01 ( US NIH Grant/Contract Award Number )
Study First Received: April 5, 2011
Results First Received: December 2, 2015
Last Updated: April 12, 2016
Health Authority: United States: Federal Government