Clinical trial NCT03598855: Ischemic Preconditioning and Type 2 Diabetes
Official title: Does Daily Ischaemic Preconditioning Improve Blood Vessel Function and Insulin Sensitivity in Type 2 Diabetes Mellitus?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Liverpool John Moores University
Sponsor class: OTHER
Collaborators: name: Liverpool University Hospitals NHS Foundation Trust
First posted: 2018-07-26
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in vascular function
timeFrame: Change from before the intervention, to immediately following the intervention, to 8 days following the end of the intervention
Secondary outcomes:
measure: Change cerebrovascular function
timeFrame: Change from before the intervention, to immediately following the intervention, to 8 days following the end of the intervention
Other outcomes:
measure: Change in insulin sensitivity
timeFrame: Change from before the intervention, to immediately following the intervention, to 8 days following the end of the intervention
Locations:
city: Liverpool
country: United Kingdom
facility: Research Institute for Sport and Exercise Sciences (RISES)
state: Merseyside
Study officials:
References: