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Ischemic Preconditioning and Type 2 Diabetes

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Ischemic Preconditioning
Sponsored by
Liverpool John Moores University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Research Institute for Sport and Exercise Sciences (RISES)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

IPC intervention

Control

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change cerebrovascular function
Change in cerebrovascular function will be assessed using transcranial Doppler ultrasound to measure brain blood flow velocity

Full Information

First Posted
July 18, 2018
Last Updated
October 3, 2018
Sponsor
Liverpool John Moores University
Collaborators
Liverpool University Hospitals NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03598855
Brief Title
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

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
May 16, 2018 (Actual)
Study Completion Date
May 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Liverpool John Moores University
Collaborators
Liverpool University Hospitals NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IPC intervention
Arm Type
Experimental
Arm Description
Participants will self administer IPC of the upper arm daily for 7 days.
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Ischemic Preconditioning
Intervention Description
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 Outcome Measure Information:
Title
Changes in vascular function
Description
Vascular function will be measured via endothelial-dependent flow-mediated dilation (FMD) of the brachial and femoral arteries and reported as percentage change.
Time Frame
Change from before the intervention, to immediately following the intervention, to 8 days following the end of the intervention
Secondary Outcome Measure Information:
Title
Change cerebrovascular function
Description
Change in cerebrovascular function will be assessed using transcranial Doppler ultrasound to measure brain blood flow velocity
Time Frame
Change from before the intervention, to immediately following the intervention, to 8 days following the end of the intervention
Other Pre-specified Outcome Measures:
Title
Change in insulin sensitivity
Description
Blood samples will be taken at each time point to assess insulin sensitivity
Time Frame
Change from before the intervention, to immediately following the intervention, to 8 days following the end of the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Research Institute for Sport and Exercise Sciences (RISES)
City
Liverpool
State/Province
Merseyside
ZIP/Postal Code
L33AF
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Ischemic Preconditioning and Type 2 Diabetes

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