Back to resultsEffect of Aerobic Interval Training on Cardiovascular Function in Type 2 Diabetes
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High intensity aerobic interval training
Continuous moderate intensity exercise
Sponsored by
About this trial
This is an interventional other trial for Type 2 Diabetes
Eligibility Criteria
Inclusion Criteria for type 2 diabetes :
- Diagnosis of type 2 diabetes
- Sedentary or minimally physically active for at least the prior 1 year
- Able to give consent
Inclusion criteria for healthy control group:
- Sedentary or minimally physically active for at least the prior 1 year
- Able to give consent
Exclusion Criteria:
- History of diabetic proliferative retinopathy, autonomic or peripheral neuropathy
- History of any relevant cardiovascular diseases (myocardial infarction, angina pectoris, history of coronary artery bypass surgery or angioplasty, congestive heart failure, or arrhythmia)
- Hypertension (≥160 mmHg systolic or ≥100 mmHg diastolic)
- History of renal impairment
- History of gout or hyperuricemia
- History of hepatic disease or infection with hepatitis B, C
- History of seizures, or other relevant on-going or recurrent illness
- Recent (within 3 months) or recurrent hospitalizations
- Use of tobacco products
- >5 % weight change in the prior 6 months.
- Current intake of medications that may affect study results
- Premenopausal women taking oral contraceptives and postmenopausal women taking hormone replacement therapy.
- Pregnancy (positive urine pregnancy test) or lactation
- For the healthy control group, history of diabetes.
Sites / Locations
- University of Florida
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
No Intervention
No Intervention
Arm Label
High intensity aerobic interval training
Continuous moderate intensity exercise
Non-exercise control group
Healthy control group
Arm Description
Type 2 diabetes subjects will complete 8 weeks of high intensity aerobic interval exercise training.
Type 2 diabetes subjects will complete 8 weeks of continuous moderate intensity exercise training.
Type 2 diabetes subjects assigned to the non-exercise control group will maintain their normal lifestyle for 8 weeks.
Healthy subjects will be assigned to the healthy control group and will undergo baseline measures only.
Outcomes
Primary Outcome Measures
Change in vascular endothelial function
Brachial flow mediated dilation using ultrasonography
Secondary Outcome Measures
Change in factors related with endothelial function
Blood and cellular markers of adiponectin, oxidative stress and inflammation.
Change in arterial stiffness
Arterial stiffness (pulse wave velocity) and wave reflection (augmentation index) will be measured using the SphygmoCor device.
Change in cardiac function
Left ventricular systolic and diastolic function will be measured using echocardiography.
Change in maximal oxygen consumption
Maximal oxygen consumption will be measured using online computer-assisted open-circuit spirometry during incremental treadmill exercise.
Full Information
NCT ID
NCT01883258
First Posted
June 13, 2013
Last Updated
December 5, 2019
Sponsor
University of Florida
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT01883258
Brief Title
Effect of Aerobic Interval Training on Cardiovascular Function in Type 2 Diabetes
Official Title
Mechanisms of Cardiovascular Dysfunction and Effect of Aerobic Exercise Training in Adults With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
May 2013 (Actual)
Primary Completion Date
July 16, 2018 (Actual)
Study Completion Date
July 16, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study objectives are:
To compare cardiovascular function in type 2 diabetes patients vs. healthy controls.
To compare the effect of 8 weeks of aerobic interval training versus continuous moderate exercise on cardiovascular function in adults with type 2 diabetes.
To examine the mechanisms underlying the exercise-related changes in cardiovascular function.
The investigators hypothesize that compared to continuous moderate intensity exercise training, interval training will be more effective in improving cardiovascular function in adults with type 2 diabetes.
Detailed Description
Cardiovascular function will be measured at baseline in adults with type 2 diabetes and in age-matched healthy controls. Research volunteers with type 2 diabetes who meet the inclusion criteria will be randomized to the aerobic interval training group, continuous moderate exercise group or non-exercise control group. At the end of the 8-week randomized control exercise intervention, baseline measures will be repeated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
116 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High intensity aerobic interval training
Arm Type
Experimental
Arm Description
Type 2 diabetes subjects will complete 8 weeks of high intensity aerobic interval exercise training.
Arm Title
Continuous moderate intensity exercise
Arm Type
Experimental
Arm Description
Type 2 diabetes subjects will complete 8 weeks of continuous moderate intensity exercise training.
Arm Title
Non-exercise control group
Arm Type
No Intervention
Arm Description
Type 2 diabetes subjects assigned to the non-exercise control group will maintain their normal lifestyle for 8 weeks.
Arm Title
Healthy control group
Arm Type
No Intervention
Arm Description
Healthy subjects will be assigned to the healthy control group and will undergo baseline measures only.
Intervention Type
Other
Intervention Name(s)
High intensity aerobic interval training
Intervention Description
Supervised aerobic interval training will be performed on bicycles 4 times per week for 8 weeks. Each training session will last 40 minutes and will consist of 10-minute warm up at 70% of maximal heart rate (HRmax), four 4-minute intervals at 90% of HRmax with 3-min active recovery at 70% of HRmax and 5-minute cool down at 70% of HRmax.
Intervention Type
Other
Intervention Name(s)
Continuous moderate intensity exercise
Intervention Description
Supervised exercise training will be performed on bicycles 4 times per week for 8 weeks. Each training session will last 47 minutes and will consist of continuous moderate intensity cycling at 70% of HRmax.
Primary Outcome Measure Information:
Title
Change in vascular endothelial function
Description
Brachial flow mediated dilation using ultrasonography
Time Frame
At baseline and after 8 weeks of exercise training
Secondary Outcome Measure Information:
Title
Change in factors related with endothelial function
Description
Blood and cellular markers of adiponectin, oxidative stress and inflammation.
Time Frame
At baseline and after 8 weeks of exercise training
Title
Change in arterial stiffness
Description
Arterial stiffness (pulse wave velocity) and wave reflection (augmentation index) will be measured using the SphygmoCor device.
Time Frame
At baseline and after 8 weeks of exercise training
Title
Change in cardiac function
Description
Left ventricular systolic and diastolic function will be measured using echocardiography.
Time Frame
At baseline and after 8 weeks of exercise training
Title
Change in maximal oxygen consumption
Description
Maximal oxygen consumption will be measured using online computer-assisted open-circuit spirometry during incremental treadmill exercise.
Time Frame
At baseline and after 8 weeks of exercise training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for type 2 diabetes :
Diagnosis of type 2 diabetes
Sedentary or minimally physically active for at least the prior 1 year
Able to give consent
Inclusion criteria for healthy control group:
Sedentary or minimally physically active for at least the prior 1 year
Able to give consent
Exclusion Criteria:
History of diabetic proliferative retinopathy, autonomic or peripheral neuropathy
History of any relevant cardiovascular diseases (myocardial infarction, angina pectoris, history of coronary artery bypass surgery or angioplasty, congestive heart failure, or arrhythmia)
Hypertension (≥160 mmHg systolic or ≥100 mmHg diastolic)
History of renal impairment
History of gout or hyperuricemia
History of hepatic disease or infection with hepatitis B, C
History of seizures, or other relevant on-going or recurrent illness
Recent (within 3 months) or recurrent hospitalizations
Use of tobacco products
>5 % weight change in the prior 6 months.
Current intake of medications that may affect study results
Premenopausal women taking oral contraceptives and postmenopausal women taking hormone replacement therapy.
Pregnancy (positive urine pregnancy test) or lactation
For the healthy control group, history of diabetes.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Demetra D Christou, Ph.D
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Aerobic Interval Training on Cardiovascular Function in Type 2 Diabetes
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