NCT00863993

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2009

Typical duration for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 18, 2009

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

February 12, 2015

Status Verified

February 1, 2015

Enrollment Period

3 years

First QC Date

March 17, 2009

Last Update Submit

February 11, 2015

Conditions

Gastric Bypass Surgery

Outcome Measures

Primary Outcomes (1)

  • TDEE (total daily energy expenditure)

    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.

    March 2009 to October 2013

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Undergoing gastric bypass surgery, 18-60 years

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

March 17, 2009

First Posted

March 18, 2009

Study Start

October 1, 2009

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

February 12, 2015

Record last verified: 2015-02