ATP Release and Sympathetic Nerve Activity in Patients With Type II Diabetes
1 other identifier
interventional
45
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 type-2-diabetes
Started Feb 2013
Longer than P75 for phase_1 type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 19, 2013
CompletedFirst Posted
Study publicly available on registry
December 5, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedJune 16, 2015
June 1, 2015
3.5 years
November 19, 2013
June 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Glucose metabolism
12 weeks
Study Arms (3)
High intensity exercise
EXPERIMENTAL3 times per week in a total of 12 weeks
Low intensity exercise
EXPERIMENTAL3 times per week in a total of 12 weeks
Control
EXPERIMENTALNormal lifestyle for 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Type 2 diabetics
- BMI \>30
- Non smokers
- Physical Inactive (less than 2 hours per week)
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre of Inflammation and Metabolism (CIM), Rigshospitalet, Tagensvej 20, section M7641
Copenhagen, 2100, Denmark
Related Publications (1)
Groen MB, Knudsen TA, Finsen SH, Pedersen BK, Hellsten Y, Mortensen SP. Reduced skeletal-muscle perfusion and impaired ATP release during hypoxia and exercise in individuals with type 2 diabetes. Diabetologia. 2019 Mar;62(3):485-493. doi: 10.1007/s00125-018-4790-0. Epub 2019 Jan 3.
PMID: 30607464DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Stefan P. Mortensen, Dr. Med.
Centre of Inflammation and Metabolism
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- CIM administrator
Study Record Dates
First Submitted
November 19, 2013
First Posted
December 5, 2013
Study Start
February 1, 2013
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
June 16, 2015
Record last verified: 2015-06