Fatty Acid Metabolism and Insulin Sensitivity After Exercise in Obesity
1 other identifier
interventional
7
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Aug 2003
Longer than P75 for not_applicable obesity
1 active site
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
Study Start
First participant enrolled
August 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 11, 2011
CompletedFirst Posted
Study publicly available on registry
October 14, 2011
CompletedNovember 23, 2016
November 1, 2016
7.7 years
October 11, 2011
November 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Insulin Sensitivity
frequently sampled intravenous glucose tolerance test(FSIVGTT)will be done to assess insuiln sensitivity
3 hours
Study Arms (2)
Exercise
EXPERIMENTAL90 min exercise on Day 1
Sedentary Control
EXPERIMENTALSubjects remain sedentary on Day 1 and will either consume a hyper-caloric or a caloric balanced diet
Interventions
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)\]
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).
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.
Eligibility Criteria
You may qualify if:
- Premenopausal; Body mass index 30-40 kg/m2; Waist circumference \>88 cm
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Michigan Clincal Research Unit
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey F Horowitz, Ph.D.
University of Michigan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Movement Science, School of Kinesiology
Study Record Dates
First Submitted
October 11, 2011
First Posted
October 14, 2011
Study Start
August 1, 2003
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
November 23, 2016
Record last verified: 2016-11