Effects of Sleeve Gastrectomy on Calcium Metabolism and the Skeleton

Sponsor

San Francisco Veterans Affairs Medical Center (U.S. Fed)

Overall Status

Active, not recruiting

CT.gov ID

NCT02778490

Collaborator

University of California, San Francisco (Other), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

Enrollment

Location

59.5

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Calcium Metabolism Disorders Morbid Obesity

Study Design

Study Type:

Observational

Anticipated 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 :

Jun 15, 2016

Anticipated Primary Completion Date :

Feb 28, 2021

Anticipated Study Completion Date :

May 31, 2021

Outcome Measures

Primary Outcome Measures

Change in intestinal fractional calcium absorption [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

Percentage change in spinal volumetric bone mineral density [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 [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 [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

Percentage change in spinal volumetric bone mineral density by QCT [6 months]
Percentage change in volumetric bone mineral density at the distal tibia by HR-pQCT [6 months]
Percentage change in cortical porosity at the distal tibia by HR-pQCT [6 months]
Percentage changes in cortical and trabecular volumetric bone mineral density and microstructural parameters at the radius and tibia by HR-pQCT [6 months and 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCSF	San Francisco	California	United States	94143

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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

Other Study ID Numbers:

R01DK107629
R01DK107629

First Posted:

May 20, 2016

Last Update Posted:

Oct 22, 2020

Last Verified:

Oct 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Anne Schafer, Assistant Professor of Medicine and of Epidemiology and Biostatistics; Staff Physician, San Francisco Veterans Affairs Medical Center

sleeve gastrectomy, bariatric surgery

Additional relevant MeSH terms:

Obesity, Morbid

Metabolic Diseases

Calcium Metabolism Disorders

Study Results

No Results Posted as of Oct 22, 2020