Clinical trial NCT01883258: Effect of Aerobic Interval Training on Cardiovascular Function in Type 2 Diabetes
Official title: Mechanisms of Cardiovascular Dysfunction and Effect of Aerobic Exercise Training in Adults With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2013-06-21
Enrollment: 116
Sex: ALL
Minimum age (years): 30
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility 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.

Primary outcomes:
measure: Change in vascular endothelial function
timeFrame: At baseline and after 8 weeks of exercise training
Secondary outcomes:
measure: Change in factors related with endothelial function
timeFrame: At baseline and after 8 weeks of exercise training
measure: Change in arterial stiffness
timeFrame: At baseline and after 8 weeks of exercise training
measure: Change in cardiac function
timeFrame: At baseline and after 8 weeks of exercise training
measure: Change in maximal oxygen consumption
timeFrame: At baseline and after 8 weeks of exercise training
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Demetra D Christou, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: