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Trial registered on ANZCTR
Registration number
ACTRN12606000200583
Ethics application status
Not yet submitted
Date submitted
15/05/2006
Date registered
29/05/2006
Date last updated
29/05/2006
Type of registration
Prospectively registered
Titles & IDs
Public title
Effect of Rosiglitazone on Glucocorticoid-stimulated 11betaHSD-1 Activity in Skeletal Muscle
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Scientific title
Does Rosiglitazone Inhibit Glucocorticoid-stimulated 11betaHSD-1 Activity in Skeletal Muscle of Subjects with Type 2 diabetes?
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes
1178
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Condition category
Condition code
Metabolic and Endocrine
1261
1261
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0
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Rosiglitazone 8mg per day orally for 24 days.
Dexamethasone 4mg per day for 4 days orally, commencing on Day 18 of the Rosiglitazone treatment
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Intervention code [1]
1037
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Treatment: Drugs
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Comparator / control treatment
Rosiglitazone 8mg per day orally for 24 days without additional treatment.
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Control group
Active
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Outcomes
Primary outcome [1]
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Skeletal muscle 11betaHSD-1 activity. Skeletal muscle 11betaHSD-1 activity refers to the activity of an enzyme which converts the inactive steroid cortisone to the active steroid cortisol. We are studying this enzyme in muscle. It is also found in liver and adipose tissue.
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Assessment method [1]
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Timepoint [1]
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Measured at day 0 and 22.
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Secondary outcome [1]
3047
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Skeletal muscle 11betaHSD-1 mRNA
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Assessment method [1]
3047
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Timepoint [1]
3047
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Day 0 vs Day 22
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Secondary outcome [2]
3048
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Skeletal muscle hexose 6 phosphate dehydrogenase mRNA
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Assessment method [2]
3048
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Timepoint [2]
3048
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Day 0 vs Day 22
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Secondary outcome [3]
3049
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Insulin sensitivity as measured by iv glucose tolerance test
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Assessment method [3]
3049
0
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Timepoint [3]
3049
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Day 0 vs Day 22
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Secondary outcome [4]
3050
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Self monitored blood glucose recordings
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Assessment method [4]
3050
0
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Timepoint [4]
3050
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During the 4 days of dexamethasone treatment
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Eligibility
Key inclusion criteria
Type 2 diabetes mellitus by current WHO criteriaTreated with diet alone, metformin, sulphonylureas and/or acarboseGood understanding of written and spoken English
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Minimum age
30
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Treatment with insulin or thiazolidinedionesSignificant chronic renal impairment, estimated glomerular filtration rate (eGFR) <40ml/min and/or serum creatinine >200umol/LLiver disease as defined by alanine transaminase (ALT) >2x upper limit of laboratory normal rangeUncontrolled diabetes as defined by Haemoglobin A1c (HbA1c) >10%Unstable heart disease as defined by myocardial infarction within 3 months, class III/IV angina pectoris or congestive heart failure.Active infection of any kind.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
via computer
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/08/2006
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
1379
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Commercial sector/Industry
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Name [1]
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Glaxo Smith Kline
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Address [1]
1379
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Country [1]
1379
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Primary sponsor type
Individual
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Name
Dr Warrick Inder
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Address
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Country
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Secondary sponsor category [1]
1214
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Individual
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Name [1]
1214
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Dr Christina Jang
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Address [1]
1214
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Country [1]
1214
0
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Secondary sponsor category [2]
1215
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Commercial sector/Industry
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Name [2]
1215
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Glaxo Smith Kline
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Address [2]
1215
0
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Country [2]
1215
0
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Ethics approval
Ethics application status
Not yet submitted
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Summary
Brief summary
The study will investigate whether pretreatment with the drug Rosiglitazone attenuates the increase in activity of muscle 11betaHSD-1 following treatment with the potent steroid dexamethasone. Dexamethasone is well known to cause an increase in blood glucose levels in people with type 2 diabetes and we are investigating a possible mechanism for this.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Warrick Inder
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Address
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Department of Endocrinology
St Vincent's Hospital
41 Victoria Parade
Fitzroy VIC 3065
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Country
10226
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Australia
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Phone
10226
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+61 3 92882211
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Fax
10226
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+61 3 92882581
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Email
10226
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[email protected]
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Contact person for scientific queries
Name
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Dr Christina Jang
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Address
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Department of Endocrinology
St Vincent's Hospital
41 Victoria Parade
Fitzroy VIC 3065
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Country
1154
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Australia
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Phone
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+61 3 92883574
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Fax
1154
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+61 3 92883590
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Email
1154
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[email protected]
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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.
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