ATP Release and Sympathetic Nerve Activity in Patients With Type II Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2016-08-31

Brief Summary

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Type II diabetes (T2D) is characterized by endothelial dysfunction, resulting in a poor tissue perfusion and function as well as an increased risk of cardiovascular events. ATP, which is released from the red blood cells, contributes to the regulation of the blood flow and studies have shown that red blood cells taken from T2D patients have an impaired ability to release ATP. However, it is not known whether the changes in the ATP system is an underlying cause of the poor tissue perfusion observed in T2D. The purpose of project 1 is to test the hypothesis that the deterioration in blood flow in T2D is caused by a reduced release ATP from red blood cells, and to test if pharmacological manipulation of cAMP will normalize ATP release, plasma ATP levels and thereby blood flow.

Furthermore, epidemiological studies show a clear link between regular exercise and a reduced risk of serious cardiovascular disease. The extent to which a physically active lifestyle may improve endothelial function in T2D is unknown. Regular physical activity improves vascularization and induces an anti-inflammatory environment. Both the angiogenic and anti-inflammatory effects of physical activity is in part mediated by substances released from the active muscle. These muscle-derived substances are classified as myokines and have paracrine, autocrine and endocrine effects and may thereby affect distant tissues. The purpose of the project 2 is to investigate whether high intensity interval training may reverse endothelial dysfunction in T2D through increased release of ATP and myokines. In individuals with T2D we will determined blood flow in the muscle tissue using advanced ultrasound. In addition, using intravascular and intramuscular microdialysis we will determine ATP levels in blood and in the muscle interstitium.

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Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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High intensity exercise

3 times per week in a total of 12 weeks

Group Type EXPERIMENTAL

Exercise training

Intervention Type BEHAVIORAL

Low intensity exercise

3 times per week in a total of 12 weeks

Group Type EXPERIMENTAL

Exercise training

Intervention Type BEHAVIORAL

Control

Normal lifestyle for 12 weeks

Group Type EXPERIMENTAL

Exercise training

Intervention Type BEHAVIORAL

Interventions

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Exercise training

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetics
* BMI \>30
* Non smokers
* Physical Inactive (less than 2 hours per week)

Exclusion Criteria

* Thyroid disorder
* Known ischemic heart disease (intermittent claudication, angina)
* Diabetic eye disease
* Diabetic kidney disease
* Known heart disease
* Intake of beta-blockers
* Blood Pressure \> 140/90
* Nephropathy and macroalbuminuria GFR measurement
* Acute illness within the last three weeks
* Chronic disease, including cancer, heart (ischemic and claudication), liver, kidney and respiratory disorders (asthma)
* Significant peripheral diabetic neuropathy (severe sensory disturbances)
* Significant peripheral diabetic angiopathy (former or current foot ulcer)
* Rheumatological disorders
* Pregnancy or childbirth within the past three months
* Alcohol abuse
* smokers
* Use of illegal performance-enhancing drugs (see IAAF list)
* Injuries and / or surgery within the last 6 months

Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No