Bariatric Surgery Outcomes

NCT01057784 | Withdrawn

• 1 other identifier: 09-11-095
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Morbid Obesity

Keywords

obesity; bariatric; surgery; sleeve; gastric bypass; vitamin D; quality of life; body composition; bone density; adolescent; child; teenager; fertility; offspring; biomarker; epigenome; gene expression

Outcome Measures

Primary Outcomes (3)

• Quality of Life.

  up to 5-year.

• Biomarkers, RNA Expression Profile, Epigenetic Markers

  up to 5-year

• Bone density/content and body composition.

  up to 5-year.

Study Arms (2)

Bariatric Surgery Patients

Patients undergoing bariatric surgery.

Procedure: Bariatric surgery.

Reproductive-Age Women - Bariatric Surgery Patients

This subgroup of patients will include 10 reproductive-age women.

Procedure: Bariatric surgery.

Interventions

Bariatric surgery. PROCEDURE

Bariatric Surgery

Bariatric Surgery Patients; Reproductive-Age Women - Bariatric Surgery Patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing bariatric surgery.

You may qualify if:

• Patients undergoing bariatric surgery.

You may not qualify if:

• None
• Reproductive-Age Women Patient Cohort:
• Patients undergoing bariatric surgery.
• Age 13-30 females.
• Weight less than 350lbs (to accommodate imaging).

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Children's Hospital Los Angeles: collaborator

Study Sites (2)

Children's Hospital - Los Angeles

Los Angeles, California, 90027, United States

Location

UCLA

Los Angeles, California, 90095, United States

Location

Related Links

• UCLA Fit for Healthy Weight Program
• UCLA Metabolic and Bariatric Surgery Program

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Obesity, Morbid; Obesity

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• Daniel DeUgarte, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 26, 2010
• First Posted: January 27, 2010
• Study Start: March 1, 2010
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: December 8, 2014

Record last verified: 2010-01

Locations

US (2)