Clinical Trial: Effects of Sleeve Gastrectomy on Calcium Metabolism and the Skeleton

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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 Summary:
Sponsor: San Francisco Veterans Affairs Medical Center

Current Primary Outcome: 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: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: San Francisco Veterans Affairs Medical Center

Dates:
Date Received: May 15, 2016
Date Started: June 15, 2016
Date Completion: May 2021
Last Updated: February 3, 2017
Last Verified: February 2017