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OpenTrials
Completed

NCT Number: NCT01451957

Fatty Acid Metabolism and Insulin Sensitivity After Exercise in Obesity

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Michigan Clincal Research Unit

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Exercise - caloric balance

Other

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)]

No Exercise - hyper-caloric diet

Other

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

Other

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

  1. Insulin Sensitivity

    Time frame: 3 hours

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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2003
Primary completion
2011
Study completion
2011
First posted
Oct 14, 2011
Registry last updated
Nov 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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