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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01883258
• Other study ID #: IRB201601534-N
• Secondary ID: 280-20121R21AG05
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Est. completion date: July 16, 2018

Study information

• Verified date: December 2019
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: July 16, 2018
• Est. primary completion date: July 16, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in vascular endothelial function	Brachial flow mediated dilation using ultrasonography	At baseline and after 8 weeks of exercise training
Secondary	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
Secondary	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
Secondary	Change in cardiac function	Left ventricular systolic and diastolic function will be measured using echocardiography.	At baseline and after 8 weeks of exercise training
Secondary	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