- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02001766
ATP Release and Sympathetic Nerve Activity in Patients With Type II Diabetes
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.
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Copenhagen, Denmark, 2100
- Recruiting
- Centre of Inflammation and Metabolism (CIM), Rigshospitalet, Tagensvej 20, section M7641
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Contact:
- Kamilla Winding, MSc PhD
- Phone Number: +45 35459574
- Email: kamilla.winding@regionh.dk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: High intensity exercise
3 times per week in a total of 12 weeks
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Experimental: Low intensity exercise
3 times per week in a total of 12 weeks
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Experimental: Control
Normal lifestyle for 12 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Glucose metabolism
Time Frame: 12 weeks
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12 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Stefan P. Mortensen, Dr. Med., Centre of Inflammation and Metabolism
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-2-2011-070
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