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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise | Experimental | exercise - supervised exercise (treadmill walking or cycle ergometer use) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | daily exercise: supervised treadmill walking or cycle ergometry use |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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).](streamdown:incomplete-link) | baseline and 24h after 5-7 days of exercise |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Thyfault, PhD | Harry S. Truman Memorial VA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harry S. Truman Memorial VA Medical Center | Columbia | Missouri | 65201-5297 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21737826 | Result | 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. | |
| 22311420 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Exercise | exercise - supervised exercise (treadmill walking or cycle ergometer use) Exercise: daily exercise: supervised treadmill walking or cycle ergometry use |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 | exercise - supervised exercise (treadmill walking or cycle ergometer use) Exercise: daily exercise: supervised treadmill walking or cycle ergometry use |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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).](streamdown:incomplete-link) | Posted | Mean | Standard Error | index score | baseline and 24h after 5-7 days of exercise |
|
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 | exercise - supervised exercise (treadmill walking or cycle ergometer use) Exercise: daily exercise: supervised treadmill walking or cycle ergometry use |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Thyfault, Associate Professor | Harry S Truman Memorial VA Hospital and University of Missouri | 573-814-6000 | 53742 | thyfaultj@health.missouri.edu |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| 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. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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) | Posted | Mean | Standard Error | percentage change | pre and 24 hours post 5-7 days of exercise |
|
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|
| 0 |
| 11 |
| 0 |
| 11 |
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| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |