Ischemic Preconditioning and Type 2 Diabetes

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03598855
• Other study ID #: IPCT2DM
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: May 16, 2018

Study information

• Verified date: July 2018
• Source: Liverpool John Moores University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: May 16, 2018
• Est. primary completion date: May 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United Kingdom	Research Institute for Sport and Exercise Sciences (RISES)	Liverpool	Merseyside

Sponsors (2)

Lead Sponsor	Collaborator
Liverpool John Moores University	Aintree University Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in insulin sensitivity	Blood samples will be taken at each time point to assess insulin sensitivity	Change from before the intervention, to immediately following the intervention, to 8 days following the end of the intervention
Primary	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	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