Energy Expenditure and Gastric Bypass Surgery

Withdrawn

• Conditions: Gastric Bypass Surgery

• Registration Number: NCT00863993
• Lead Sponsor: Mayo Clinic

Brief Summary

The aim of this study is to assess whether activity thermogenesis increases in patients undergoing bariatric surgery post-operatively compared to pre-operatively. The investigators will assess non-exercise activity thermogenesis using a validated Physical Activity Monitoring System and doubly labeled water, immediately pre-operatively and again at 6 and 18 months post-operatively. PAMS has been validated in lean and obese individuals. This is to assess energy expenditure, activity thermogenesis and NEAT during the phase of greatest weight loss and once weight loss has plateaued. This will permit us to address our primary hypothesis that activity thermogenesis as a fraction of total daily energy expenditure increases in patients undergoing bariatric surgery 6 and 18 months post-operatively, compared to pre-operatively.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2009-03-17
• Study First Submitted QC: 2009-03-17
• Study First Posted: 2009-03-18
• Study Start: 2009-10
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-11
• Last Update Posted: 2015-02-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Undergoing gastric bypass surgery, 18-60 years

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Exclusion Criteria

• Eligible subjects will be excluded who cannot walk at 2.4 mph for 15 minutes, or weigh greater than 227 kg at the screening visit.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TDEE (total daily energy expenditure)	March 2009 to October 2013	Activity thermogenesis as a fraction of total daily energy expenditure increases in patients undergoing bariatric surgery 6 and 18 months post-operatively, compared to pre-operatively.