Type 2 Diabetes Mellitus
Conditions
Brief summary
The aim of this study is to determine the impact of 7 days of daily ischemic preconditioning (IPC) on vascular function and insulin sensitivity in Type 2 Diabetes Mellitus.
Detailed description
Occlusion (cuff inflation to a pressure that reduces blood flow) using a blood pressure cuff on the upper arm for 5 mins followed by recovery (cuff deflation so blood flows normally gain), is known as ischemic preconditioning (IPC). An intervention consisting of 4 cycles of 5 min arm occlusion followed by 5 min periods of recovery on a daily basis can improve blood vessel function. This is a simple and easily applicable intervention that immediately improves the blood vessels capacity to deliver blood to an organ (e.g. heart or the muscle). However, it is currently unknown if a daily IPC can improve blood vessel function in patients with type 2 diabetes mellitus (T2DM) and if it will aid in improving blood glucose control. Therefore, the purpose of this study is to investigate if daily IPC for 7 days can improve blood vessel function and blood glucose control in T2DM. This randomised control trial consists of 3 visits to Liverpool John Moores University; before intervention, immediately following intervention, and 8 days following the end of the intervention. Participants will be trained to apply the IPC device and then perform it at home daily for 7 days.
Interventions
OTHERIschemic Preconditioning
Ischemic preconditioning (IPC) refers to cycles of 5 minutes of upper arm cuff inflation with 5 minute periods of cuff deflations, repeated 4 times.
Sponsors
Liverpool University Hospitals NHS Foundation Trust
Liverpool John Moores University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Able to provide written consent * Males and females 18-75 years * Diagnosis of T2DM * Currently treated with diet or of metformin
Exclusion criteria
* Type 1 diabetes mellitus * Previous myocardial infarction, stroke (including TIA) or thrombosis * Diagnosed with Congestive Heart failure * Unable to enroll for the duration of the study * Pregnancy or lactation period * Currently treated with sulponylureas (DDPIV inhibitors/Pioglitazone or insulin) or glucagon like peptide1
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in vascular function | Change from before the intervention, to immediately following the intervention, to 8 days following the end of the intervention | Vascular function will be measured via endothelial-dependent flow-mediated dilation (FMD) of the brachial and femoral arteries and reported as percentage change. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change cerebrovascular function | Change from before the intervention, to immediately following the intervention, to 8 days following the end of the intervention | Change in cerebrovascular function will be assessed using transcranial Doppler ultrasound to measure brain blood flow velocity |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in insulin sensitivity | Change from before the intervention, to immediately following the intervention, to 8 days following the end of the intervention | Blood samples will be taken at each time point to assess insulin sensitivity |
Countries
United Kingdom
Outcome results
None listed