Effects of Gastric Bypass Surgery and Calcium Metabolism and the Skeleton

NCT ID: NCT01330914

Last Updated: 2019-03-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2015-01-31

Brief Summary

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Obesity is a chronic illness of staggering proportions. Because weight loss through diet and exercise is difficult to attain and maintain, there has been escalating interest in bariatric surgery, including Roux-en-Y gastric bypass. Gastric bypass surgery results in long-term weight loss, dramatic improvement in comorbidities such as diabetes, and decreased mortality. Emerging evidence suggests, however, that gastric bypass may have negative effects on bone health. Because of the serious consequences of osteoporosis and fracture, this is of great concern. This study of the effects of gastric bypass on calcium metabolism and the skeleton may positively impact the clinical care of gastric bypass patients by their surgeons, primary care providers, and endocrinologists. Further, the knowledge gained may inform future investigation into the relationships between obesity, weight loss, and bone biology.

Detailed Description

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Conditions

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Obesity, Morbid Gastric Bypass

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Gastric Bypass Surgery Patients

Obese men and women undergoing gastric bypass surgery

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Scheduled to undergo gastric bypass surgery. Please note that to be eligible, one must already be working with a bariatric surgeon and with plans in place to undergo gastric bypass. This study is unable to arrange or pay for gastric bypass surgery.

Exclusion Criteria

* Perimenopausal women
* Known intestinal malabsorption
* Prior bariatric surgery
* Use of medications known to impact bone and mineral metabolism
* Disease known to affect bone
* Illicit drug use or alcohol use \>3 drinks/day
* Serum calcium \>10.2 mg/dL
* Calculated creatinine clearance \<30 mL/min
* Weight \>350 pounds
* Wrist circumference \>12 inches or calf circumference \>17 inches
Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne L Schafer, MD

Role: PRINCIPAL_INVESTIGATOR

San Francisco VA Medical Center, San Francisco, CA

Locations

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San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, United States

Site Status

Countries

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United States

References

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Schafer AL, Weaver CM, Black DM, Wheeler AL, Chang H, Szefc GV, Stewart L, Rogers SJ, Carter JT, Posselt AM, Shoback DM, Sellmeyer DE. Intestinal Calcium Absorption Decreases Dramatically After Gastric Bypass Surgery Despite Optimization of Vitamin D Status. J Bone Miner Res. 2015 Aug;30(8):1377-85. doi: 10.1002/jbmr.2467. Epub 2015 May 21.

Reference Type RESULT
PMID: 25640580 (View on PubMed)

Schafer AL, Li X, Schwartz AV, Tufts LS, Wheeler AL, Grunfeld C, Stewart L, Rogers SJ, Carter JT, Posselt AM, Black DM, Shoback DM. Changes in vertebral bone marrow fat and bone mass after gastric bypass surgery: A pilot study. Bone. 2015 May;74:140-5. doi: 10.1016/j.bone.2015.01.010. Epub 2015 Jan 17.

Reference Type RESULT
PMID: 25603463 (View on PubMed)

Chakhtoura MT, Nakhoul NF, Akl EA, Safadi BY, Mantzoros CS, Metzendorf MI, El-Hajj Fuleihan G. Oral vitamin D supplementation for adults with obesity undergoing bariatric surgery. Cochrane Database Syst Rev. 2024 Oct 1;10(10):CD011800. doi: 10.1002/14651858.CD011800.pub2.

Reference Type DERIVED
PMID: 39351881 (View on PubMed)

Other Identifiers

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1IK2CX000549-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

ENDB-007-10F

Identifier Type: -

Identifier Source: org_study_id

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