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Clinical Trials/NCT01883258
NCT01883258
Completed
Not Applicable

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

University of Florida1 site in 1 country116 target enrollmentMay 2013
ConditionsType 2 Diabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 2 Diabetes
Sponsor
University of Florida
Enrollment
116
Locations
1
Primary Endpoint
Change in vascular endothelial function
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2013
End Date
July 16, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

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.

Outcomes

Primary Outcomes

Change in vascular endothelial function

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

Brachial flow mediated dilation using ultrasonography

Secondary Outcomes

  • Change in cardiac function(At baseline and after 8 weeks of exercise training)
  • Change in factors related with endothelial function(At baseline and after 8 weeks of exercise training)
  • Change in arterial stiffness(At baseline and after 8 weeks of exercise training)
  • Change in maximal oxygen consumption(At baseline and after 8 weeks of exercise training)

Study Sites (1)

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