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Trial record 84 of 5955 for:    Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed

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

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).

Condition or disease
Calcium Metabolism Disorders Morbid Obesity

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Sleeve Gastrectomy on Calcium Metabolism and the Skeleton
Actual Study Start Date : June 15, 2016
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).


Other Outcome Measures:
  1. Percentage change in spinal volumetric bone mineral density by QCT [ Time Frame: 6 months ]
  2. Percentage change in volumetric bone mineral density at the distal tibia by HR-pQCT [ Time Frame: 6 months ]
  3. Percentage change in cortical porosity at the distal tibia by HR-pQCT [ Time Frame: 6 months ]
  4. 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 ]

Biospecimen Retention:   Samples Without DNA
serum, urine


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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Obese men and women undergoing sleeve gastrectomy surgery
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02778490


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

Locations
United States, California
UCSF Recruiting
San Francisco, California, United States, 94143
Contact: Nicole King    415-221-4810 ext 10580    nicole.king@ucsf.edu   
Contact: Anne Schafer, MD    415-221-4810 ext 24895    anne.schafer@ucsf.edu   
Sponsors and Collaborators
San Francisco Veterans Affairs Medical Center
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

Responsible Party: Anne Schafer, Assistant Professor of Medicine and of Epidemiology and Biostatistics; Staff Physician, San Francisco Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT02778490     History of Changes
Other Study ID Numbers: R01DK107629 ( U.S. NIH Grant/Contract )
R01DK107629 ( U.S. NIH Grant/Contract )
First Posted: May 20, 2016    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Anne Schafer, San Francisco Veterans Affairs Medical Center:
sleeve gastrectomy, bariatric surgery

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