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

Mechanisms of Cardiovascular Dysfunction and Effect of Aerobic Exercise Training in Adults With Type 2 Diabetes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01883258
Enrollment
116
Registered
2013-06-21
Start date
2013-05-31
Completion date
2018-07-16
Last updated
2019-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

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.

Interventions

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.

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.

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
University of Florida
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to 79 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in vascular endothelial functionAt baseline and after 8 weeks of exercise trainingBrachial flow mediated dilation using ultrasonography

Secondary

MeasureTime frameDescription
Change in factors related with endothelial functionAt baseline and after 8 weeks of exercise trainingBlood and cellular markers of adiponectin, oxidative stress and inflammation.
Change in arterial stiffnessAt baseline and after 8 weeks of exercise trainingArterial stiffness (pulse wave velocity) and wave reflection (augmentation index) will be measured using the SphygmoCor device.
Change in cardiac functionAt baseline and after 8 weeks of exercise trainingLeft ventricular systolic and diastolic function will be measured using echocardiography.
Change in maximal oxygen consumptionAt baseline and after 8 weeks of exercise trainingMaximal oxygen consumption will be measured using online computer-assisted open-circuit spirometry during incremental treadmill exercise.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026