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Completed

NCT Number: NCT00954109

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

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.

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Key information

Conditions

Insulin Resistance Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harry S. Truman Memorial VA Medical Center

Columbia, Missouri, 65201-5297, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Exercise

Behavioral

daily exercise: supervised treadmill walking or cycle ergometry use

Primary outcomes

  1. Insulin Sensitivity After 5-7 Days of Exercise

    Time frame: baseline and 24h 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).

  2. Blood Flow in Response to Oral Glucose Tolerance Tests

    Time frame: pre and 24 hours post 5-7 days of exercise

    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)

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Official study title

Physical Inactivity and Insulin Resistance in Skeletal Muscle

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 7, 2009
Registry last updated
Apr 6, 2015

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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