Ischemic Preconditioning and Type 2 Diabetes

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Other: Ischemic Preconditioning

• Registration Number: NCT03598855
• Lead Sponsor: Liverpool John Moores University

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.

Study Timeline

• Study Start: 2017-06-01
• Primary Completion: 2018-05-16
• Study Completion: 2018-05-16
• Status Verified: 2018-07
• Study First Submitted: 2018-07-18
• Study First Submitted QC: 2018-07-19
• Study First Posted: 2018-07-26
• Last Update Submitted: 2018-10-03
• Last Update Posted: 2018-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IPC intervention	Ischemic Preconditioning	Participants will self administer IPC of the upper arm daily for 7 days.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Institute for Sport and Exercise Sciences (RISES); 🇬🇧 Liverpool, Merseyside, United Kingdom