Effects of Sleeve Gastrectomy on Calcium Metabolism and the Skeleton

NCT02778490 | Completed

• 1 other identifier: R01DK107629
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Calcium Metabolism Disorders; Morbid Obesity

Keywords

sleeve gastrectomy, bariatric surgery

Outcome Measures

Primary Outcomes (1)

• Change in intestinal fractional calcium absorption

  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.

  6 months

Secondary Outcomes (3)

• Percentage change in spinal volumetric bone mineral density

  12 months

• Percentage change in volumetric bone mineral density at the distal tibia

  12 months

• Percentage change in cortical porosity at the distal tibia

  12 months

Other Outcomes (4)

• 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

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Obese men and women undergoing sleeve gastrectomy surgery

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• San Francisco Veterans Affairs Medical Center: lead
• University of California, San Francisco: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

UCSF

San Francisco, California, 94143, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum, urine

MeSH Terms

Conditions

Calcium Metabolism Disorders; Obesity, Morbid

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anne Schafer, MD

  San Francisco VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine and of Epidemiology and Biostatistics; Staff Physician

Study Record Dates

• First Submitted: May 15, 2016
• First Posted: May 20, 2016
• Study Start: June 15, 2016
• Primary Completion: November 28, 2021
• Study Completion: November 28, 2021
• Last Updated: October 28, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)