Ischemic Preconditioning and Type 2 Diabetes

NCT ID: NCT03598855

Last Updated: 2018-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2018-05-16

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.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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IPC intervention

Participants will self administer IPC of the upper arm daily for 7 days.

Group Type EXPERIMENTAL

Ischemic Preconditioning

Intervention Type 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.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ischemic 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.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Liverpool University Hospitals NHS Foundation Trust

OTHER_GOV

Sponsor Role collaborator

Liverpool John Moores University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Institute for Sport and Exercise Sciences (RISES)

Liverpool, Merseyside, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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IPCT2DM

Identifier Type: -

Identifier Source: org_study_id

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