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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Other: High intensity aerobic interval training; Other: Continuous moderate intensity exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in vascular endothelial function	Brachial flow mediated dilation using ultrasonography	At baseline and after 8 weeks of exercise training

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in factors related with endothelial function	Blood and cellular markers of adiponectin, oxidative stress and inflammation.	At baseline and after 8 weeks of exercise training
Change in arterial stiffness	Arterial stiffness (pulse wave velocity) and wave reflection (augmentation index) will be measured using the SphygmoCor device.	At baseline and after 8 weeks of exercise training
Change in cardiac function	Left ventricular systolic and diastolic function will be measured using echocardiography.	At baseline and after 8 weeks of exercise training
Change in maximal oxygen consumption	Maximal oxygen consumption will be measured using online computer-assisted open-circuit spirometry during incremental treadmill exercise.	At baseline and after 8 weeks of exercise training

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Demetra D Christou, Ph.D, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2013
• Primary Completion (Actual): July 16, 2018
• Study Completion (Actual): July 16, 2018

Study Registration Dates

• First Submitted: June 13, 2013
• First Submitted That Met QC Criteria: June 18, 2013
• First Posted (Estimate): June 21, 2013

Study Record Updates

• Last Update Posted (Actual): December 6, 2019
• Last Update Submitted That Met QC Criteria: December 5, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: IRB201601534-N; 280-2012 (Other Identifier: Legacy study); 1R21AG050203-01 (U.S. NIH Grant/Contract); OCR12584 (Other Identifier: University of Florida)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No