Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001117808
Ethics application status
Approved
Date submitted
6/10/2012
Date registered
19/10/2012
Date last updated
19/10/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Remote ischemic preconditioning in obesity and diabetes
Scientific title
The effect of ischemic preconditioning in reducing inflammation and improving glucose homeostasis in obesity.
Secondary ID [1] 281353 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 287574 0
Diabetes 287661 0
Condition category
Condition code
Diet and Nutrition 287899 287899 0 0
Obesity
Metabolic and Endocrine 288000 288000 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ischemic preconditioning will be induced by brief periods of limb ischemia (5mins) due to limb occlusion using a blood pressure cuff inflated to suprasystolic pressure and followed by 5 minutes of reperfusion for 4 cycles. This protocol of 4 cycles of occlusion and resotration of flow will be performed daily for 1 week in this study.
Intervention code [1] 285813 0
Treatment: Other
Comparator / control treatment
Each individual will act as their own control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288115 0
Serum levels of IL6 measured in a blood sample
Timepoint [1] 288115 0
1 week
Secondary outcome [1] 299453 0
Glucose and insulin levels in blood sample.
Timepoint [1] 299453 0
1 week

Eligibility
Key inclusion criteria
Obesity BMI>30. Patients may not necessarily be diabetic.
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Drug therapy, smokers.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286112 0
Charities/Societies/Foundations
Name [1] 286112 0
Murdoch Childrens Research Institute
Country [1] 286112 0
Australia
Primary sponsor type
Individual
Name
Michael Cheung
Address
Dept of Cardiology
Royal Childrens Hospital
Flemington Road
Parkville
Victoria 3052
Country
Australia
Secondary sponsor category [1] 284924 0
None
Name [1] 284924 0
Address [1] 284924 0
Country [1] 284924 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
To determine if preconditioning will have a beneficial effect on the metabolic derangements associated with obesity.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34795 0
Address 34795 0
Country 34795 0
Phone 34795 0
Fax 34795 0
Email 34795 0
Contact person for public queries
Name 18042 0
Rosa Masciantonio
Address 18042 0
MCRI
Heart Research Group
Flemington Road
Parkville
Victoria 3052
Country 18042 0
Australia
Phone 18042 0
+61-3-93455718
Fax 18042 0
Email 18042 0
[email protected]
Contact person for scientific queries
Name 8970 0
Rosa Masciantonio
Address 8970 0
MCRI
Heart Research Group
Flemington Road
Parkville
Victoria 3052
Country 8970 0
Australia
Phone 8970 0
+61-3-93455718
Fax 8970 0
Email 8970 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.