Acute Cardiovascular and Metabolic Effects of Exercise Training in Individuals With Insulin Resistance

Insulin Resistance Clinical Trial

Official title:

Physical Inactivity and Insulin Resistance in Skeletal Muscle

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00954109
• Other study ID #: CDA-2-051-07S
• Status: Completed
• Phase: N/A
• First received: August 4, 2009
• Last updated: April 3, 2015
• Start date: August 2009
• Est. completion date: December 2010

Study information

• Verified date: April 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The overall aim of the project is to determine whether or not exercise influences cardiovascular or nervous responses to meal ingestion in individuals with insulin resistance or type 2 diabetes.

Description:

Participants will undergo a screening procedure, including telephone screening and physical examination, as well as determination of body composition and fitness. Participants will be asked to complete 5-10 days of supervised exercise training and will undergo testing to assess cardiovascular and metabolic responses to an oral glucose tolerance test, including muscle sympathetic nerve activity, blood flow, and circulating glucose and insulin concentrations at baseline and following training. In addition, day-to-day variations in blood glucose will also be monitored. The overall aim of the project is to determine whether or not acute exercise training influences postprandial metabolic, vascular or autonomic nervous system responses in individuals with insulin resistance or T2D.

Other known NCT identifiers

• NCT00572676

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• Insulin resistant: diagnosed with pre-diabetes or fasting blood glucose >/= 100 mg/dL

• T2D: diagnosed by primary care physician

• BMI: less than 43 kg/m2

• Age: 30-65

Exclusion Criteria:

• Smoking

• Insulin use (other than once daily)

• Underlying conditions that limit ability to exercise safely

• Recent weight gain or loss (>5% of body weight in 3 months)

• Physically active (>30 min aerobic exercise, 2 d/wk)

• Recent (<3 mo) changes in medication use or dose

• Uncontrolled T2D (HbA1c>10%)

• Advanced retinopathy or neuropathy

• Pregnancy

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insulin Resistance

Intervention

Behavioral:
• Exercise
daily exercise: supervised treadmill walking or cycle ergometry use

Locations

Country	Name	City	State
United States	Harry S. Truman Memorial VA Medical Center	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

Mikus CR, Fairfax ST, Libla JL, Boyle LJ, Vianna LC, Oberlin DJ, Uptergrove GM, Deo SH, Kim A, Kanaley JA, Fadel PJ, Thyfault JP. Seven days of aerobic exercise training improves conduit artery blood flow following glucose ingestion in patients with type — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin Sensitivity After 5-7 Days of Exercise	Insulin sensitivity measured during an oral glucose tolerance test measured by the Matsuda Index. Matsuda insulin sensitivity index= 10000/square root of [(fasting glucose × fasting insulin) × (mean glucose × mean insulin during oral glucose tolerance test).	baseline and 24h after 5-7 days of exercise	No
Primary	Blood Flow in Response to Oral Glucose Tolerance Tests	Blood flow response in the femoral artery measured by Doppler ultrasound during and oral glucose tolerance test. Data are represented as % change in blood flow during the oral glucose tolerance at 60 minutes vs. 0 minutes (prior to drinking the glucose)	pre and 24 hours post 5-7 days of exercise	No