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

June 15, 2015 updated by: Anders Rasmussen Rinnov

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

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Recruiting
        • Centre of Inflammation and Metabolism (CIM), Rigshospitalet, Tagensvej 20, section M7641
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: High intensity exercise
3 times per week in a total of 12 weeks
Behavioral: Exercise training
Experimental: Low intensity exercise
3 times per week in a total of 12 weeks
Behavioral: Exercise training
Experimental: Control
Normal lifestyle for 12 weeks
Behavioral: Exercise training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glucose metabolism
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anders Rasmussen Rinnov

Investigators

  • Study Chair: Stefan P. Mortensen, Dr. Med., Centre of Inflammation and Metabolism

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

August 1, 2016

Study Registration Dates

First Submitted

November 19, 2013

First Submitted That Met QC Criteria

November 28, 2013

First Posted (Estimate)

December 5, 2013

Study Record Updates

Last Update Posted (Estimate)

June 16, 2015

Last Update Submitted That Met QC Criteria

June 15, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2-2011-070

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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