Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000237381
Ethics application status
Approved
Date submitted
14/04/2008
Date registered
8/05/2008
Date last updated
8/05/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Detection of exogenous insulin in blood and urine in type I diabetics and non diabetics.
Scientific title
Detection of exogenous insulin (in blood and urine) as a doping agent in 6 type I diabetics and 6 non diabetics, both male and female, aged 18 to 45. An open label cross over study.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sports doping detection 3047 0
Condition category
Condition code
Metabolic and Endocrine 3201 3201 0 0
Diabetes
Metabolic and Endocrine 3202 3202 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Type I diabetic participants take their usual insulin dose and provide blood and urine samples at baseline and for up to 24 hours.
Non diabetic participants are administered intravenous (IV) Actrapid insulin 0.05iu/kg at visit 1, 70g oral glucose at visit 2 and placebo at visit 3. Blood and urine samples are collected at each visit at baseline then for up to 24 hours. There is a 5 day washout period between visit 1 (insulin administration) and visit 2 (glucose administration). There is no specified washout period between visit 2 and visit 3 (placebo administration).
Intervention code [1] 2797 0
Treatment: Drugs
Comparator / control treatment
Acting as their own controls, and non diabetics are compared with diabetics re: metabolism of exogenous insulin.
Control group
Active

Outcomes
Primary outcome [1] 4089 0
Bioassay measurement of exogenous insulin levels in blood and urine in both groups of participants.
Timepoint [1] 4089 0
Samples of blood and urine are taken at baseline and at intervals over 24 hours at each visit.
Secondary outcome [1] 6882 0
None
Timepoint [1] 6882 0
None

Eligibility
Key inclusion criteria
Type I diabetics:
on insulin therapy
Male or female
Aged 18 to 45.
Non diabetics:
Healthy
Male or female
Aged 18 to 45
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
In non diabetic group:
Coronary artery disease
epilepsy
diabetes
elite athletes
pregnancy

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
The non diabetic particpants were in the interventional crossover design.
The diabetics were observed following administration of usual clinical treatment
Phase
Phase 3 / Phase 4
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3298 0
Government body
Name [1] 3298 0
World Anti Doping Agency (WADA)
Country [1] 3298 0
Canada
Primary sponsor type
Hospital
Name
Concord Repatriation General Hospital
Address
Hospital Road Concord NSW 2139
Country
Australia
Secondary sponsor category [1] 2952 0
None
Name [1] 2952 0
Address [1] 2952 0
Country [1] 2952 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5283 0
Concord Hospital HREC
Ethics committee address [1] 5283 0
Ethics committee country [1] 5283 0
Australia
Date submitted for ethics approval [1] 5283 0
10/08/2007
Approval date [1] 5283 0
21/08/2007
Ethics approval number [1] 5283 0
CH62/6/2006-066 - P Liu

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28526 0
Address 28526 0
Country 28526 0
Phone 28526 0
Fax 28526 0
Email 28526 0
Contact person for public queries
Name 11683 0
Peter Liu
Address 11683 0
Dept of Andrology
Building 22
Concord Hospital
Hospital Road
Conocrd NSW 2139
Country 11683 0
Australia
Phone 11683 0
02 9767 7222
Fax 11683 0
02 9767 7221
Email 11683 0
[email protected]
Contact person for scientific queries
Name 2611 0
Peter Liu
Address 2611 0
Dept of Andrology
Concord Hospital
Concord NSW 2139
Country 2611 0
Australia
Phone 2611 0
02 9767 7222
Fax 2611 0
02 9767 7221
Email 2611 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.