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

University of Florida

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Other: Continuous moderate intensity exercise; Other: High intensity aerobic interval training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01883258

OCR12584 (Other Identifier)

1R21AG050203-01 (U.S. NIH Grant/Contract)

IRB201601534-N

280-2012 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 116 patients

Sex: All

Ages: 30 to 79 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

116 participants in 4 patient groups

High intensity aerobic interval training

Experimental group

Description:

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

Treatment:

Other: High intensity aerobic interval training

Continuous moderate intensity exercise

Experimental group

Description:

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

Treatment:

Other: Continuous moderate intensity exercise

Non-exercise control group

No Intervention group

Description:

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

Healthy control group

No Intervention group

Description:

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