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

Primary Purpose

Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insulin Resistance focused on measuring Insulin Resistance, Type 2 Diabetes

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Harry S. Truman Memorial VA Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exercise

Arm Description

exercise - supervised exercise (treadmill walking or cycle ergometer use)

Outcomes

Primary Outcome Measures

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).
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)

Secondary Outcome Measures

Full Information

First Posted
August 4, 2009
Last Updated
April 3, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00954109
Brief Title
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

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance
Keywords
Insulin Resistance, Type 2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
exercise - supervised exercise (treadmill walking or cycle ergometer use)
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
daily exercise: supervised treadmill walking or cycle ergometry use
Primary Outcome Measure Information:
Title
Insulin Sensitivity After 5-7 Days of Exercise
Description
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).
Time Frame
baseline and 24h after 5-7 days of exercise
Title
Blood Flow in Response to Oral Glucose Tolerance Tests
Description
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)
Time Frame
pre and 24 hours post 5-7 days of exercise

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Thyfault, PhD
Organizational Affiliation
Harry S. Truman Memorial VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harry S. Truman Memorial VA Medical Center
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201-5297
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21737826
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.
Results Reference
result
PubMed Identifier
22311420
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.
Results Reference
derived

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

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