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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01883258
First received: June 13, 2013
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Type 2 Diabetes
Other: High intensity aerobic interval training
Other: Continuous moderate intensity exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Mechanisms of Cardiovascular Dysfunction and Effect of Aerobic Exercise Training in Adults With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Change in vascular endothelial function [ Time Frame: At baseline and after 8 weeks of exercise training ] [ Designated as safety issue: No ]
    Brachial flow mediated dilation using ultrasonography


Secondary Outcome Measures:
  • Change in factors related with endothelial function [ Time Frame: At baseline and after 8 weeks of exercise training ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Maximal oxygen consumption will be measured using online computer-assisted open-circuit spirometry during incremental treadmill exercise.


Estimated Enrollment: 118
Study Start Date: May 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   30 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01883258

Contacts
Contact: Demetra D Christou, Ph.D 352-294-1715 ddchristou@ufl.edu

Locations
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32611
Contact: Demetra D Christou, Ph.D    352-294-1715    ddchristou@ufl.edu   
Principal Investigator: Demetra D Christou, Ph.D         
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Demetra D Christou, Ph.D University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01883258     History of Changes
Other Study ID Numbers: 280-2012
Study First Received: June 13, 2013
Last Updated: July 17, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 25, 2014