Clinical trial NCT00954109: Acute Cardiovascular and Metabolic Effects of Exercise Training in Individuals With Insulin Resistance
Official title: Physical Inactivity and Insulin Resistance in Skeletal Muscle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Keywords: Insulin Resistance
Type 2 Diabetes
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2009-08-07
Enrollment: 11
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Insulin Sensitivity After 5-7 Days of Exercise
timeFrame: baseline and 24h after 5-7 days of exercise
measure: Blood Flow in Response to Oral Glucose Tolerance Tests
timeFrame: pre and 24 hours post 5-7 days of exercise
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Harry S. Truman Memorial VA Medical Center
state: Missouri
Study officials:
affiliation: Harry S. Truman Memorial VA Medical Center
name: John Thyfault, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 2 diabetes. J Appl Physiol (1985). 2011 Sep;111(3):657-64. doi: 10.1152/japplphysiol.00489.2011. Epub 2011 Jul 7.
citation: Mikus CR, Oberlin DJ, Libla J, Boyle LJ, Thyfault JP. Glycaemic control is improved by 7 days of aerobic exercise training in patients with type 2 diabetes. Diabetologia. 2012 May;55(5):1417-23. doi: 10.1007/s00125-012-2490-8. Epub 2012 Feb 4.