Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2010-03-31
2014-07-31
Brief Summary
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Detailed Description
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2. Health Survey: The purpose of evaluating physical and mental health is to document changes that occur following surgery. Standardized surveys will include SF-36, (Bariatric Analysis and Reporting Outcome System), BAROS, and Epworth Sleepiness Scale. Our hypothesis is that bariatric surgery will improve quality of life for the majority of patients.
3. Reproductive-Age Women:
While the number of bariatric procedures performed has increased to over 200,000 annually, this number represents only a small fraction of those that qualify. The prevalence of extreme obesity is higher in women than in men (7% vs. 3%), and women are disproportionately more likely to undergo bariatric surgery. Nearly 80% of patients undergoing bariatric surgery are female and 35% are less than 40 years of age.
Given the current demographics of metabolic/bariatric surgery and the epidemic of childhood obesity, it is important to evaluate the long-term impact of bariatric surgery on nutrition, pregnancy, offspring health, and bone density. Despite previous concerns, metabolic/bariatric surgery has been demonstrated to improve maternal outcomes and likely improves neonatal outcomes. Interestingly, weight-loss surgery has been demonstrated to reduce the incidence of obesity in offspring by 50%. It is unclear whether improvements in offspring health are related to changes in the uterine environment, the post-natal environment, or the epigenome.
While obesity has been associated with Vitamin D deficiency and hyperparathyroidism, it is not usually associated with the development of osteoporosis. Bariatric surgery can impair calcium absorption and exacerbate vitamin deficiencies. However, the impact of surgery on bone mineral content and density is unclear. This has particular ramifications for young female patients and the risk of osteoporosis long-term.
The purpose is this portion of the study is to evaluate the impact of metabolic/bariatric surgery on reproductive-age women (age 13 to 30) with respect to weight, nutritional status, body composition, biomarker/epigenome profile, markers of atherosclerosis, and bone mineral content/density.
1. Obstetrical/Offspring Health and Fertility: The purpose of this assessment is to evaluate the impact of surgery on obstetrical complications, offspring health, and fertility. A simple questionnaire will be administered to women of reproductive age.
2. Biomarkers /Epigenetic Markers: The purpose of collecting specimens (e.g. blood) and analyzing changes in hormones, biologic markers, and epigenetic markers is to help elucidate potential mechanism involved in weight loss.
3. Imaging: In collaboration with Children's Hospital - Los Angeles, we will coordinate imaging to evaluate body composition, bone density/content, and subclinical markers of atherosclerosis. Imaging studies will include DEXA (dual x-ray absorptiometry) for patients under 300 lbs, low-dose CT-scan for patients under 350 lbs, and ultrasound of the vessels of the neck.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Bariatric Surgery Patients
Patients undergoing bariatric surgery.
Bariatric surgery.
Bariatric Surgery
Reproductive-Age Women - Bariatric Surgery Patients
This subgroup of patients will include 10 reproductive-age women.
Bariatric surgery.
Bariatric Surgery
Interventions
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Bariatric surgery.
Bariatric Surgery
Eligibility Criteria
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Inclusion Criteria
* Patients undergoing bariatric surgery.
* Age 13-30 females.
* Weight less than 350lbs (to accommodate imaging).
Exclusion Criteria
2. Reproductive-Age Women Patient Cohort:
ALL
No
Sponsors
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Children's Hospital Los Angeles
OTHER
University of California, Los Angeles
OTHER
Responsible Party
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UCLA
Principal Investigators
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Daniel DeUgarte, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Locations
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Children's Hospital - Los Angeles
Los Angeles, California, United States
UCLA
Los Angeles, California, United States
Countries
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Related Links
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UCLA Fit for Healthy Weight Program
UCLA Metabolic and Bariatric Surgery Program
Other Identifiers
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09-11-095
Identifier Type: -
Identifier Source: org_study_id