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Completed

NCT Number: NCT03598855

Ischemic Preconditioning and Type 2 Diabetes

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research Institute for Sport and Exercise Sciences (RISES)

Liverpool, Merseyside, L33AF, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ischemic Preconditioning

Other

Ischemic preconditioning (IPC) refers to cycles of 5 minutes of upper arm cuff inflation with 5 minute periods of cuff deflations, repeated 4 times.

Primary outcomes

  1. Changes in vascular function

    Time frame: 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 outcomes

  1. Change cerebrovascular function

    Time frame: 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 outcomes

  1. Change in insulin sensitivity

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Liverpool John Moores University

Other

Collaborators

  • Liverpool University Hospitals NHS Foundation Trust

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 26, 2018
Registry last updated
Oct 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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