Ischemic Preconditioning and Type 2 Diabetes

Liverpool John Moores University

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Other: Ischemic Preconditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT03598855

IPCT2DM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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21 participants in 2 patient groups

IPC intervention

Experimental group

Description:

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

Treatment:

Other: Ischemic Preconditioning

Control

No Intervention group