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

NCT ID: NCT01883258

Last Updated: 2019-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2018-07-16

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

High intensity aerobic interval training

Type 2 diabetes subjects will complete 8 weeks of high intensity aerobic interval exercise training.

Group Type: EXPERIMENTAL

High intensity aerobic interval training

Intervention Type: 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

Type 2 diabetes subjects will complete 8 weeks of continuous moderate intensity exercise training.

Group Type: EXPERIMENTAL

Continuous moderate intensity exercise

Intervention Type: 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.

Non-exercise control group

Type 2 diabetes subjects assigned to the non-exercise control group will maintain their normal lifestyle for 8 weeks.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Healthy control group

Healthy subjects will be assigned to the healthy control group and will undergo baseline measures only.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diagnosis of type 2 diabetes
• Sedentary or minimally physically active for at least the prior 1 year
• Able to give consent

• 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Demetra D Christou, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida

Gainesville, Florida, United States

Countries

United States

Other Identifiers

280-2012

Identifier Type: OTHER

Identifier Source: secondary_id

1R21AG050203-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

OCR12584

Identifier Type: OTHER

Identifier Source: secondary_id

IRB201601534-N

Identifier Type: -

Identifier Source: org_study_id