Ischemic Preconditioning and Type 2 Diabetes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Does Daily Ischaemic Preconditioning Improve Blood Vessel Function and Insulin Sensitivity in Type 2 Diabetes Mellitus?

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Other: Ischemic Preconditioning


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IPC intervention<br>Participants will self administer IPC of the upper arm daily for 7 days. | Other: Ischemic Preconditioning<br>* Ischemic preconditioning (IPC) refers to cycles of 5 minutes of upper arm cuff inflation with 5 minute periods of cuff deflations, repeated 4 times.<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in vascular function | Vascular function will be measured via endothelial-dependent flow-mediated dilation (FMD) of the brachial and femoral arteries and reported as percentage change. | Change from before the intervention, to immediately following the intervention, to 8 days following the end of the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change cerebrovascular function | Change in cerebrovascular function will be assessed using transcranial Doppler ultrasound to measure brain blood flow velocity | Change from before the intervention, to immediately following the intervention, to 8 days following the end of the intervention |