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Completed

NCT Number: NCT01883258

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

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.

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Key information

Age range

30 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High intensity aerobic interval training

Other

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.

Continuous moderate intensity exercise

Other

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 outcomes

  1. Change in vascular endothelial function

    Time frame: At baseline and after 8 weeks of exercise training

    Brachial flow mediated dilation using ultrasonography

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Jun 21, 2013
Registry last updated
Dec 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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