Exercise Intensity, Metabolic Rate and Insulin Sensitivity

Healthy Women Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01879891
• Other study ID #: 5R01DK049779-14
• Status: Completed
• Phase: N/A
• First received: June 13, 2013
• Last updated: October 24, 2016
• Start date: May 1995

Study information

• Verified date: October 2016
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: National Institute of HealthUnited States: DHHS
• Study type: Interventional

Clinical Trial Summary

The primary goal is to test the hypothesis high interval exercise increases energy expenditure and Insulin sensitivity more than 2 days of rest or moderate intensity exercise cumulatively over 23 hours during and following the exercise. Secondary goals are to evaluate exercise difficulty during moderate intensity exercise and high interval exercise as well as difficulty of activities of daily living and free living physical activity following rest, moderate intensity exercise and high interval exercise.

A secondary study is designed to evaluate potential mechanism. Hypotheses are that changes in muscle lipid metabolism, mitochondrial function, fat and cellular insulin signals will be increased following the high intensity interval exercise. In addition, these changes will be related to changes in insulin sensitivity and increases in protein metabolism and muscle damage.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 42 Years

Eligibility

Inclusion Criteria:

• healthy premenopausal African-American or Caucasian women ages 19 - 42

Exclusion Criteria:

• subjects cannot be smoking,

• taking medications which alter energy expenditure or fuel utilization,

• be diabetic or have a body mass index (BMI) less than 18 or more than 35.

• Also subjects cannot be pregnant or have cardiopulmonary disease.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Women

Intervention

Other:
• Aerobic
Exercise training will consist of bicycle ergometer riding starting at 67% of heart rate max for 20 minutes. Exercise Intensity will be progressively increased every week until 80% of heart rate max for 40 minute sessions is reached.

Locations

Country	Name	City	State
United States	UAB	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise Intensity	To test the hypothesis that high interval exercise increases energy expenditure and Insulin sensitivity more than 2 days of rest or moderate intensity exercise cumulatively over 23 hours during and following the exercise	16 weeks	No
Secondary	Exercise Difficulty	To evaluate exercise difficulty during moderate intensity exercise and high interval exercise as well as difficulty of activities of daily living and free living physical activity following rest, moderate intensity exercise and high interval exercise	16 weeks	No