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WithdrawnNCT00863993Updated Feb 12, 2015

Energy Expenditure and Gastric Bypass Surgery

An observational study in Gastric Bypass Surgery, sponsored by Mayo Clinic. Withdrawn. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2015-02-12.

Sponsored by Mayo Clinic · Observational

Why this study was withdrawn
no patients enrolled.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Gastric Bypass Surgery
03

In context

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
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.

Inclusion criteria

  • Undergoing gastric bypass surgery, 18-60 years

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
06

What researchers measure

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.

    Time frame: March 2009 to October 2013

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00863993
Lead sponsor
Mayo Clinic
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party
James Levine (Professor of Medicine, Mayo Clinic) — Principal investigator
First posted
Mar 18, 2009
Start date
Oct 2009
Primary completion
Oct 2012
Completion
Oct 2012
Last update
Feb 12, 2015

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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