Energy Expenditure and Gastric Bypass Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Mayo Clinic.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
James Levine, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00863993
First received: March 17, 2009
Last updated: October 24, 2011
Last verified: October 2011
  Purpose

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.


Condition
Gastric Bypass Surgery

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

Further study details as provided by Mayo Clinic:

Estimated Enrollment: 40
Study Start Date: December 2006
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

40 healthy patients (M=F, aged 18-60 years) undergoing gastric bypass bariatric surgery will be recruited.

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.
  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: NCT00863993

Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97201-4753
Sponsors and Collaborators
Mayo Clinic
  More Information

No publications provided

Responsible Party: James Levine, Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00863993     History of Changes
Other Study ID Numbers: 05-004359, R01DK072479
Study First Received: March 17, 2009
Last Updated: October 24, 2011
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on October 01, 2014