None listed
Conditions
Brief summary
This randomised controlled trial aims to establish if there is a correlation between diabetic neuropathy (nerve pathways affected by diabetes) and markers of blood vessel health in response to remote ischaemic conditioning (RIC). Via activation of nerves and beneficial compounds within the blood, RIC is known to protect areas at a distance from damage caused by a more prolonged and serious lack of oxygen-rich arterial blood flow in some patients. Methodology 60 randomly recruited adult participants residing in the Armidale region with type 2 diabetes will have a baseline diabetic history taken, detailed physical examination and measurements collected. Non-invasive cardiovascular physiological measurements will be obtained prior to, during and up to 24 hours after the intervention. The RIC intervention consists of 5 mins upper arm ischaemia (brief cessation of oxygen-rich blood flow), with blood pressure cuff inflation to 200mmHg, followed by 5 mins of complete cuff deflation. This cycle will be repeated 3 times without delay between cycles. In the control group, the intervention will be the same, except cuff pressures inflated to a lower pressure. Venous blood samples will be collected immediately before intervention, then 15 and 60 minutes after RIC. Changes in markers of blood vessel health will be the primary outcome measure. Secondary outcome measures will include changes in blood levels of markers of inflammation and physiological changes of the heart and circulation Results will be correlated with variables. Blood samples will also be tested for blood sugar levels, full blood count, HbA1c (measure of diabetes control), and lipids. Aims of the study The study aims to provide a clearer insight into the mechanisms of RIC, assist in predicting which diabetic patients are most likely to benefit from RIC, and potentially guide the development of new therapeutic strategies for the vascular complications of diabetes.
Interventions
The intervention is remote ischaemic conditioning (RIC): a single session of 4 repeated cycles of 5 minute blood pressure cuff inflation to 200mmHg followed by 5 minutes of cuff deflation on the non-dominant upper arm. The RIC exposure will be applied by a general practitioner member of the research team with >10 years of clinical experience, or a suitably trained researcher, at either the Sport UNE Exercise Physiology laboratory at the University of New England (UNE), or the University Medical
The intervention is remote ischaemic conditioning (RIC): a single session of 4 repeated cycles of 5 minute blood pressure cuff inflation to 200mmHg followed by 5 minutes of cuff deflation on the non-dominant upper arm. The RIC exposure will be applied by a general practitioner member of the research team with >10 years of clinical experience, or a suitably trained researcher, at either the Sport UNE Exercise Physiology laboratory at the University of New England (UNE), or the University Medical Centre at the UNE. The RIC involves the use of a standard pneumatic blood pressure cuff and sphygmomanometer. The researcher will be present throughout the intervention. Ischaemia will be confirmed by absence of the radial pulse and pulse oximetry on the cuffed arm during each cuff inflation. Participants will be asked to avoid alcohol, caffeine and minimise physical exercise for 24 hours prior to the study until study completion.
Sponsors
University of New England
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Type 2 diabetic participants, with or without diabetic neuropathy
Exclusion criteria
Inability to provide informed consent Pregnancy, breastfeeding Proliferative diabetic retinopathy (or no eye examination within preceding 12 months) Hypocalcaemia Smoker within previous 12 months Chronic atrial flutter or fibrillation Bleeding disorders, warfarin (or equivalent) therapy Anti-VEGF therapy Lymphoedema or known vascular abnormality in upper limbs Previous or current DVT Severe systolic hypertension (>180mmHg) Haematological malignancy Recent severe acute illness
Outcome results
None listed