Ischemic Preconditioning and Type 2 Diabetes
Does Daily Ischaemic Preconditioning Improve Blood Vessel Function and Insulin Sensitivity in Type 2 Diabetes Mellitus?
1 other identifier
interventional
21
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable type-2-diabetes-mellitus
Started Jun 2017
Shorter than P25 for not_applicable type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 16, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 16, 2018
CompletedFirst Submitted
Initial submission to the registry
July 18, 2018
CompletedFirst Posted
Study publicly available on registry
July 26, 2018
CompletedOctober 4, 2018
July 1, 2018
12 months
July 18, 2018
October 3, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Change cerebrovascular function
Change from before the intervention, to immediately following the intervention, to 8 days following the end of the intervention
Other Outcomes (1)
Change in insulin sensitivity
Change from before the intervention, to immediately following the intervention, to 8 days following the end of the intervention
Study Arms (2)
IPC intervention
EXPERIMENTALParticipants will self administer IPC of the upper arm daily for 7 days.
Control
NO INTERVENTIONInterventions
Ischemic preconditioning (IPC) refers to cycles of 5 minutes of upper arm cuff inflation with 5 minute periods of cuff deflations, repeated 4 times.
Eligibility Criteria
You may qualify if:
- Able to provide written consent
- Males and females 18-75 years
- Diagnosis of T2DM
- Currently treated with diet or of metformin
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Research Institute for Sport and Exercise Sciences (RISES)
Liverpool, Merseyside, L33AF, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2018
First Posted
July 26, 2018
Study Start
June 1, 2017
Primary Completion
May 16, 2018
Study Completion
May 16, 2018
Last Updated
October 4, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share