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Energy Expenditure and Gastric Bypass Surgery

This study has been withdrawn prior to enrollment.
(no patients enrolled.)
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
James Levine, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00863993
First received: March 17, 2009
Last updated: February 11, 2015
Last verified: February 2015
  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:

Primary Outcome Measures:
  • TDEE (total daily energy expenditure) [ Time Frame: March 2009 to October 2013 ] [ Designated as safety issue: No ]
    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.


Enrollment: 0
Study Start Date: October 2009
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
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.

No Contacts or Locations Provided
  More Information

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: February 11, 2015
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on September 27, 2016