Energy Expenditure and Gastric Bypass Surgery

NCT ID: NCT00863993

Last Updated: 2015-02-12

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2012-10-31

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.

Conditions

Gastric Bypass Surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Undergoing gastric bypass surgery, 18-60 years

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

James Levine

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

R01DK072479

Identifier Type: NIH

Identifier Source: secondary_id

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05-004359

Identifier Type: -

Identifier Source: org_study_id