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Bariatric Surgery Outcomes

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Children's Hospital Los Angeles
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01057784
First received: January 26, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

The UCLA Metabolic and Bariatric Surgery Program (adult program) and the UCLA Fit for Healthy Weight Program (adolescent program) are committed to the care of morbidly obese patients. This study is observational. The investigators plan to evaluate bariatric surgery outcomes using the BAROS National Database and also to evaluate quality of life pre- and post bariatric surgery. In addition, the investigators plan to enroll a subgroup of 10 reproductive-age women to evaluate: 1) pregnancy and offspring health, 2) long-term nutrition, 3) biomarkers/epigenome, and 4) body-composition/bone-density.


Condition Intervention
Morbid Obesity
Procedure: Bariatric surgery.

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bariatric Surgery Outcomes: Quality of Life / Reproductive-Age Women

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Quality of Life. [ Time Frame: Pre-operative, 1-year, 2-year, and 5-year. ] [ Designated as safety issue: No ]
  • Biomarkers, RNA Expression Profile, Epigenetic Markers [ Time Frame: Pre-operative, 1-year, 2-year, and 5-year ] [ Designated as safety issue: No ]
  • Bone density/content and body composition. [ Time Frame: Pre-operative, 1-year, 2-year, and 5-year. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

The subgroup of 10 reproductive-age women will have coded bloods samples retained for DNA and RNA analysis.


Estimated Enrollment: 1000
Study Start Date: March 2010
Groups/Cohorts Assigned Interventions
Bariatric Surgery Patients
Patients undergoing bariatric surgery.
Procedure: Bariatric surgery.
Bariatric Surgery
Reproductive-Age Women - Bariatric Surgery Patients
This subgroup of patients will include 10 reproductive-age women.
Procedure: Bariatric surgery.
Bariatric Surgery

Detailed Description:
  1. National Database: The purpose of the Bariatric Outcomes Longitudinal Database (BOLD) study is to study the mid- and long-term outcomes of bariatric surgeries and to analyze the relationship between these outcomes and 1) patient demographics and comorbidities, 2) clinical and surgical characteristics, and 3) pre-operative, peri-operative, and post-operative care and treatment. The UCLA program will be just one of many institutions that participate in the BOLD study. Participants include other programs and surgeons who have received a Full Approval or Provisional Status designation in the American Society for Bariatric Surgery (ASBS) Bariatric Surgery Center for Excellence program. This study, along with the database itself, is being established, maintained and overseen by East Carolina University in association with the Surgical Review Corporation.
  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.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing bariatric surgery.

Criteria
  1. Bariatric Surgery Patient Cohort:

    Inclusion Criteria:

    • Patients undergoing bariatric surgery.

    Exclusion Criteria:

    • None
  2. Reproductive-Age Women Patient Cohort:

Inclusion Criteria:

  • Patients undergoing bariatric surgery.
  • Age 13-30 females.
  • Weight less than 350lbs (to accommodate imaging).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01057784

Locations
United States, California
Children's Hospital - Los Angeles
Los Angeles, California, United States, 90027
UCLA
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Children's Hospital Los Angeles
Investigators
Principal Investigator: Daniel DeUgarte, MD University of California, Los Angeles
  More Information

Additional Information:
No publications provided

Responsible Party: Daniel DeUgarte, MD, UCLA
ClinicalTrials.gov Identifier: NCT01057784     History of Changes
Other Study ID Numbers: 09-11-095
Study First Received: January 26, 2010
Last Updated: January 26, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
obesity
bariatric
surgery
sleeve
gastric bypass
vitamin D
quality of life
body composition
bone density
adolescent
child
teenager
fertility
offspring
biomarker
epigenome
gene expression

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

ClinicalTrials.gov processed this record on November 25, 2014