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Effects of Sleeve Gastrectomy on Calcium Metabolism and the Skeleton

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ClinicalTrials.gov Identifier: NCT02778490
Recruitment Status : Recruiting
First Posted : May 20, 2016
Last Update Posted : June 27, 2018
Sponsor:
Collaborators:
University of California, San Francisco
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Anne Schafer, San Francisco Veterans Affairs Medical Center

Tracking Information
First Submitted Date May 15, 2016
First Posted Date May 20, 2016
Last Update Posted Date June 27, 2018
Actual Study Start Date June 15, 2016
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 19, 2016)
Change in intestinal fractional calcium absorption [ Time Frame: 6 months ]
The investigators will determine whether there is a change in intestinal calcium absorption, assessed using the dual stable isotopes Ca-43 and Ca-44 in the setting of robust vitamin D status, following sleeve gastrectomy.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02778490 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 19, 2016)
  • Percentage change in spinal volumetric bone mineral density [ Time Frame: 12 months ]
    The investigators will define the effects of sleeve gastrectomy on spinal volumetric bone mineral density, assessed by quantitative computed tomography (QCT).
  • Percentage change in volumetric bone mineral density at the distal tibia [ Time Frame: 12 months ]
    The investigators will define the effects of sleeve gastrectomy on total volumetric bone mineral density at the distal tibia, assessed by high-resolution peripheral quantitative computed tomography (HR-pQCT).
  • Percentage change in cortical porosity at the distal tibia [ Time Frame: 12 months ]
    The investigators will define the effects of sleeve gastrectomy on cortical porosity at the distal tibia, assessed by high-resolution peripheral quantitative computed tomography (HR-pQCT).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 19, 2016)
  • Percentage change in spinal volumetric bone mineral density by QCT [ Time Frame: 6 months ]
  • Percentage change in volumetric bone mineral density at the distal tibia by HR-pQCT [ Time Frame: 6 months ]
  • Percentage change in cortical porosity at the distal tibia by HR-pQCT [ Time Frame: 6 months ]
  • Percentage changes in cortical and trabecular volumetric bone mineral density and microstructural parameters at the radius and tibia by HR-pQCT [ Time Frame: 6 months and 12 months ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Effects of Sleeve Gastrectomy on Calcium Metabolism and the Skeleton
Official Title Effects of Sleeve Gastrectomy on Calcium Metabolism and the Skeleton
Brief Summary In this pre-post observational study, the investigators will enroll and follow a cohort of about 50 adults undergoing sleeve gastrectomy surgery for weight loss. Pre-operatively and at 6 and 12 months post-operatively, the investigators will use state-of-the-art metabolic and imaging techniques to evaluate calcium metabolism and skeletal health. Specific outcomes include intestinal calcium absorption capacity, bone mineral density (BMD) assessed by dual-energy X-ray absorptiometry (DXA) and quantitative computed tomography (QCT), and bone structure assessed by QCT and high-resolution peripheral QCT (HR-pQCT).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
serum, urine
Sampling Method Non-Probability Sample
Study Population Obese men and women undergoing sleeve gastrectomy surgery
Condition
  • Calcium Metabolism Disorders
  • Morbid Obesity
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 19, 2016)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2021
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Women and men 25 to 70 years old scheduled to undergo sleeve gastrectomy

Please note that the investigators are unable to provide sleeve gastrectomy; rather, potential participants must already be planning the procedure with their surgeons.

Exclusion Criteria:

  • Perimenopausal women, defined as last menses >3 months but < 5 years ago
  • Known intestinal malabsorption (e.g., celiac disease, short gut syndrome, prior intestinal surgery)
  • Prior bariatric surgery
  • Use of medications known to impact bone and mineral metabolism, including use of a bisphosphonate or teriparatide in the last year or for >12 months ever; current calcitonin; prednisone >5 mg daily or the equivalent glucocorticoid for >10 days in the last 3 months; a current thiazolidinedione (TZD); an aromatase inhibitor; androgen deprivation therapy; an antiepileptic agent known to alter hepatic vitamin D clearance; or thyroid hormone replacement with current thyroid stimulating hormone < 0.1 milli-international units per liter
  • Disease known to affect bone (e.g., primary hyperparathyroidism, Pagets disease, clinically significant liver disease)
  • Illicit drug use or alcohol use >3 drinks/day
  • Serum calcium >10.2 mg/dL or calculated creatinine clearance < 30 mL/min
  • Weight >350 pounds (the maximum weight limit of the QCT scanner) at the time of the pre-operative QCT scan
Sex/Gender
Sexes Eligible for Study: All
Ages 25 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Anne Schafer, MD 415-221-4810 ext 24895 anne.schafer@ucsf.edu
Contact: Heather Freasier, RD 415-221-4810 ext 25518 heather.freasier@va.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02778490
Other Study ID Numbers R01DK107629( U.S. NIH Grant/Contract )
R01DK107629 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Anne Schafer, San Francisco Veterans Affairs Medical Center
Study Sponsor San Francisco Veterans Affairs Medical Center
Collaborators
  • University of California, San Francisco
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Anne Schafer, MD San Francisco VA Medical Center
PRS Account San Francisco Veterans Affairs Medical Center
Verification Date June 2018