Energy Expenditure and Gastric Bypass Surgery Study (Energy)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Mayo Clinic
Information provided by (Responsible Party):
Bruce Wolfe, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00671957
First received: May 2, 2008
Last updated: October 14, 2015
Last verified: October 2015
  Purpose

The aim of this study is to assess whether the energy you burn daily increases after you have bariatric surgery. Until now, there hasn't been an effective way of measuring all activity on a daily basis. Physical Activity Monitoring System (PAMS) has been created just for this purpose. PAMS is a garment that can be worn under your clothes, that records body position and movement through space. We will use the PAMS along with special water to measure your total daily energy expenditure right before surgery, and again 6 months and 24 months after surgery.

Study subjects will be initially recruited from OHSU IRB-Approved advertisements. Interested study subjects will be screened through an informal telephone interview. If there are no health conditions that exclude participation, subjects will be asked to give IRB-approved consent.

Subjects will be consenting to undergo three 18 day phases. Each phase will consist of 15 daily visits to the Clinical & Translational Research Center (CTRC), and 3 full day and nights in the CTRC.


Condition
Morbid Obesity

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Energy Expenditure and Gastric Bypass Surgery Study

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • To compare physical activity and activity thermogenesis in patients undergoing gastric bypass bariatric surgery at baseline (pre-operatively) and 6 and 24 months after gastric bypass surgery. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate whether changes in weight correlate with changes in activity thermogenesis in patients undergoing gastric bypass surgery at baseline (pre-operatively) and 6 and 24 months after gastric bypass surgery. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • To evaluate the changes in basal metabolic rate (BMR) and thermic effect of food (TEF) in patients undergoing gastric bypass surgery at baseline (pre-operatively) and 6 and 24 months after gastric bypass surgery. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: February 2006
Estimated Study Completion Date: September 2016
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients undergoing gastric bypass surgery and who are participants in Longitudinal Assessment of Bariatric Surgery (LABS-2)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Morbidly obese patients undergoing Bariatric surgery.
Criteria

Inclusion Criteria:

  • No acute illnesses
  • Weight less than 227 kg (limit of Bod Pod and Treadmill)
  • Able to walk at 2.4 mph for 15 minutes (needed for the energy expenditure testing)
  • No tobacco use
  • Ability to stop alcohol consumption during test phases
  • For female subjects; no plans for pregnancy in 24 months and menstrual cycles of 21-35 days
  • No history of eating disorder
  • No history of current substance abuse
  • No history of chest pain or shortness of breath at rest or on exertion.
  • Negative pregnancy in women.

Exclusion Criteria:

  • Informed consent not obtained
  • Prior bariatric surgery
  • Unlikely to comply with follow-up protocol (e.g., travel time from home too long to make visits feasible, unwilling to return for follow-up visits)
  • Unable to communicate with local study staff
  • Lactating women
  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: NCT00671957

Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Mayo Clinic
Investigators
Principal Investigator: Bruce M Wolfe, MD Oregon Health and Science University
  More Information

Responsible Party: Bruce Wolfe, Professor of Surgery, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00671957     History of Changes
Other Study ID Numbers: IRB00002212 
Study First Received: May 2, 2008
Last Updated: October 14, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Obesity
Bariatric
Surgery
Activity

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

ClinicalTrials.gov processed this record on July 28, 2016