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CompletedNCT01451957Updated Nov 23, 2016

Fatty Acid Metabolism and Insulin Sensitivity After Exercise in Obesity

An interventional study of Exercise - caloric balance and No Exercise - hyper-caloric diet in Obesity, sponsored by University of Michigan. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-23.

Sponsored by University of Michigan · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
7
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

Alterations in fatty acid mobilization and oxidation may be primary adaptations responsible for the improvements in metabolic health after a single session of endurance exercise. The investigators will determine the effect of a single session of endurance exercise on whole-body fatty acid mobilization and oxidation, IMTG concentration and the expression of factors that regulate these processes in skeletal muscle of 11 women with abdominal obesity (age: 18-45y). In addition, the investigators will evaluate how these factors, and exercise, effect insulin signalling and insulin sensitivity. Every effort will be made to recruit subjects from ethnic and minority groups. Before participating in the study, subjects will be informed of all the procedures and potential risks, and they will sign an informed consent form approved by The University of Michigan Institutional Review Board. Eligible volunteers will participate in three separate trials, in a randomized order. In two trials subjects will eat exactly the same amount of calories, except in one trial they will exercise (eucaloric + exercise) and in the other trial they will remain sedentary (hypercaloric). In a third trial subjects will again remain sedentary but instead they will ingest appropriate calories to maintain caloric balance (eucaloric + sedentary). By doing this the investigators are also able to investigate the effect of acute caloric perturbations on insulin sensitivity, because it is possible that the enhanced insulin sensitivity evident after exercise, as compared to the sedentary state, is due to caloric deficit and not the exercise bout, per se.

02

Conditions studied

  • Obesity

Keywords

  • exercise
  • fatty acid metabolism
  • insulin sensitivity
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 7 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Premenopausal; Body mass index 30-40 kg/m2; Waist circumference >88 cm

Exclusion criteria

Exclusion Criteria:

  • Evidence of metabolic or cardiovascular disease; Pregnancy; Hyperlipidemia (fasting plasma triglyceride concentration > 150 mg/dl); Hematocrit \< 34%; Undertaking regular exercise (i.e., >2 times/week)
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    Exercise

    90 min exercise on Day 1

    Other: Exercise - caloric balance

  • Experimental
    Sedentary Control

    Subjects remain sedentary on Day 1 and will either consume a hyper-caloric or a caloric balanced diet

    Other: No Exercise - hyper-caloric diet · Other: No exercise - caloric balance

Interventions

  • OtherExercise - caloric balance

    90 min exercise on Day 1 with meals afterward resulting in caloric balance for the day (i.e.; extra kcals provided to account for energy expended during exercise)\]

  • OtherNo Exercise - hyper-caloric diet

    Subjects remain sedentary on Day 1 and they ingest meals that are identical to those ingested on the day they performed exercise (i.e.; more calories ingested than expended because no exercise performed).

  • OtherNo exercise - caloric balance

    Subjects remain sedentary on Day 1 and they ingest a similar proportion of macronutrients however, the total calories ingested will be lower than the other two trials, resulting in caloric balance for the day.

06

What researchers measure

Primary outcomes

  1. Insulin Sensitivity

    frequently sampled intravenous glucose tolerance test(FSIVGTT)will be done to assess insuiln sensitivity

    Time frame: 3 hours

07

Study locations

1 site
  • Michigan Clincal Research Unit
    Ann Arbor, Michigan 48109, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 23, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01451957
Lead sponsor
University of Michigan
Responsible party
Jeffrey F Horowitz (Associate Professor, Movement Science, School of Kinesiology, University of Michigan) — Principal investigator
First posted
Oct 14, 2011
Start date
Aug 2003
Primary completion
Apr 2011
Completion
Apr 2011
Last update
Nov 23, 2016

Study contacts

Jeffrey F Horowitz, Ph.D.
principal investigator · University of Michigan

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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