This trial is active, not recruiting.

Condition obesity
Treatments exercise - caloric balance, no exercise - hyper-caloric diet, no exercise - caloric balance
Sponsor University of Michigan
Start date August 2003
End date April 2011
Trial size 7 participants
Trial identifier NCT01451957, 03-0165


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose basic science
90 min exercise on Day 1
exercise - 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)]
Subjects remain sedentary on Day 1 and will either consume a hyper-caloric or a caloric balanced diet
no 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).
no 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.

Primary Outcomes

Insulin Sensitivity
time frame: 3 hours

Eligibility Criteria

Female participants from 18 years up to 45 years old.

Inclusion Criteria: - Premenopausal; Body mass index 30-40 kg/m2; Waist circumference >88 cm 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)

Additional Information

Official title Fatty Acid Metabolism and Insulin Sensitivity After Exercise in Obesity
Principal investigator Jeffrey F Horowitz, Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University of Michigan.