Energy Expenditure and Gastric Bypass Surgery Study (Energy)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00671957|
Recruitment Status : Suspended (Funding hiatus)
First Posted : May 6, 2008
Last Update Posted : April 9, 2018
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 or disease|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Energy Expenditure and Gastric Bypass Surgery Study|
|Study Start Date :||February 2006|
|Actual Primary Completion Date :||July 2007|
|Estimated Study Completion Date :||September 2019|
Patients undergoing gastric bypass surgery and who are participants in Longitudinal Assessment of Bariatric Surgery (LABS-2)
- 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 ]
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00671957
|United States, Oregon|
|Oregon Health & Science University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Bruce M Wolfe, MD||Oregon Health and Science University|