Effect of Aerobic Interval Training on Cardiovascular Function in Type 2 Diabetes
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|ClinicalTrials.gov Identifier: NCT01883258|
Recruitment Status : Recruiting
First Posted : June 21, 2013
Last Update Posted : November 19, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Other: High intensity aerobic interval training Other: Continuous moderate intensity exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||123 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Mechanisms of Cardiovascular Dysfunction and Effect of Aerobic Exercise Training in Adults With Type 2 Diabetes|
|Study Start Date :||May 2013|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||November 2019|
Experimental: High intensity aerobic interval training
Type 2 diabetes subjects will complete 8 weeks of high intensity aerobic interval exercise training.
Other: High intensity aerobic interval training
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.
Experimental: Continuous moderate intensity exercise
Type 2 diabetes subjects will complete 8 weeks of continuous moderate intensity exercise training.
Other: Continuous moderate intensity exercise
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.
No Intervention: Non-exercise control group
Type 2 diabetes subjects assigned to the non-exercise control group will maintain their normal lifestyle for 8 weeks.
No Intervention: Healthy control group
Healthy subjects will be assigned to the healthy control group and will undergo baseline measures only.
- Change in vascular endothelial function [ Time Frame: At baseline and after 8 weeks of exercise training ]Brachial flow mediated dilation using ultrasonography
- Change in factors related with endothelial function [ Time Frame: At baseline and after 8 weeks of exercise training ]Blood and cellular markers of adiponectin, oxidative stress and inflammation.
- Change in arterial stiffness [ Time Frame: At baseline and after 8 weeks of exercise training ]Arterial stiffness (pulse wave velocity) and wave reflection (augmentation index) will be measured using the SphygmoCor device.
- Change in cardiac function [ Time Frame: At baseline and after 8 weeks of exercise training ]Left ventricular systolic and diastolic function will be measured using echocardiography.
- Change in maximal oxygen consumption [ Time Frame: At baseline and after 8 weeks of exercise training ]Maximal oxygen consumption will be measured using online computer-assisted open-circuit spirometry during incremental treadmill exercise.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01883258
|Contact: Demetra D Christou, Ph.Dfirstname.lastname@example.org|
|United States, Florida|
|University of Florida||Recruiting|
|Gainesville, Florida, United States, 32611|
|Contact: Demetra D Christou, Ph.D 352-294-1715 email@example.com|
|Principal Investigator: Demetra D Christou, Ph.D|
|Principal Investigator:||Demetra D Christou, Ph.D||University of Florida|