Effect of Aerobic Interval Training on Cardiovascular Function in Type 2 Diabetes

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Other: High intensity aerobic interval training; Other: Continuous moderate intensity exercise

• Registration Number: NCT01883258
• Lead Sponsor: University of Florida

Brief Summary

The study objectives are:

1. To compare cardiovascular function in type 2 diabetes patients vs. healthy controls.

2. To compare the effect of 8 weeks of aerobic interval training versus continuous moderate exercise on cardiovascular function in adults with type 2 diabetes.

3. 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-06-13
• Study First Submitted QC: 2013-06-18
• Study First Posted: 2013-06-21
• Primary Completion: 2018-07-16
• Study Completion: 2018-07-16
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-05
• Last Update Posted: 2019-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

Not provided

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High intensity aerobic interval training	High intensity aerobic interval training	Type 2 diabetes subjects will complete 8 weeks of high intensity aerobic interval exercise training.
Continuous moderate intensity exercise	Continuous moderate intensity exercise	Type 2 diabetes subjects will complete 8 weeks of continuous moderate intensity exercise training.

Primary Outcome Measures

Name	Time	Method
Change in vascular endothelial function	At baseline and after 8 weeks of exercise training	Brachial flow mediated dilation using ultrasonography

Secondary Outcome Measures

Name	Time	Method
Change in factors related with endothelial function	At baseline and after 8 weeks of exercise training	Blood and cellular markers of adiponectin, oxidative stress and inflammation.
Change in arterial stiffness	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	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	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.

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States