Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000423314
Ethics application status
Not yet submitted
Date submitted
1/08/2008
Date registered
25/08/2008
Date last updated
25/08/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of statin ingestion on muscle function at rest and following acute exercise in humans
Scientific title
Effect of simvastatin ingestion on muscle function at rest and following acute exercise in healthy humans
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Statin-induced myopathy 3498 0
Condition category
Condition code
Other 3652 3652 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Healthy males (18-35yrs) will ingest 80 mg/day of simvastatin for 28 days and then perform a single bout (1hr) of prolonger moderate intensiity exercise.
Intervention code [1] 3219 0
Treatment: Drugs
Comparator / control treatment
Placebo group in doubel blinded fashion. Placebo will be an identical sugar pill. Placebo will be taken orally once per day for 28 days.
Control group
Placebo

Outcomes
Primary outcome [1] 4556 0
To assess disturbance in skeletal muscle mitochondrial function. Biochemical assays will be performed on muscle biopsy samples to analyse mitochondrial enzyme function and protein expression. Also signalling proteins and their gene transcripts will be measured to assess mitochondrial biogenesis.
Timepoint [1] 4556 0
4 weeks
Secondary outcome [1] 7706 0
Markers of mitochondrial biogenesis, including PGC-1 alpha, NFR-1, Tfam and AMPK will be assessed in muscle biopsy samples.
Timepoint [1] 7706 0
4 weeks

Eligibility
Key inclusion criteria
Healthy males, (18-35yrs) normal renal, liver and thyroid function. no other mediciations for histories of diease.
Minimum age
18 Years
Maximum age
35 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
abnormal renal, thyroid and liver function

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3670 0
University
Name [1] 3670 0
The University of Melbourne
Country [1] 3670 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Grattan St, Parkville, Victoria, 3010
Country
Australia
Secondary sponsor category [1] 3296 0
None
Name [1] 3296 0
Address [1] 3296 0
Country [1] 3296 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 5724 0
Ethics committee address [1] 5724 0
Ethics committee country [1] 5724 0
Date submitted for ethics approval [1] 5724 0
04/08/2008
Approval date [1] 5724 0
Ethics approval number [1] 5724 0

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

Contacts
Principal investigator
Name 28802 0
Address 28802 0
Country 28802 0
Phone 28802 0
Fax 28802 0
Email 28802 0
Contact person for public queries
Name 11959 0
Dr Craig Goodman
Address 11959 0
Department of Physiology, The University of Melbourne, Grattan St, Parkville, 3010
Country 11959 0
Australia
Phone 11959 0
03 8344 6669
Fax 11959 0
Email 11959 0
[email protected]
Contact person for scientific queries
Name 2887 0
Dr Craig Goodman
Address 2887 0
Department of Physiology, The University of Melbourne, Grattan St, Parkville, 3010
Country 2887 0
Australia
Phone 2887 0
03 8344 6669
Fax 2887 0
Email 2887 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.