Trial Review

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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
Scientific title
Does Rosiglitazone Inhibit Glucocorticoid-stimulated 11betaHSD-1 Activity in Skeletal Muscle of Subjects with Type 2 diabetes?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 1178 0
Condition category
Condition code
Metabolic and Endocrine 1261 1261 0 0
Diabetes

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 1037 0
Treatment: Drugs
Comparator / control treatment
Rosiglitazone 8mg per day orally for 24 days without additional treatment.
Control group
Active

Outcomes
Primary outcome [1] 1699 0
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.
Timepoint [1] 1699 0
Measured at day 0 and 22.
Secondary outcome [1] 3047 0
Skeletal muscle 11betaHSD-1 mRNA
Timepoint [1] 3047 0
Day 0 vs Day 22
Secondary outcome [2] 3048 0
Skeletal muscle hexose 6 phosphate dehydrogenase mRNA
Timepoint [2] 3048 0
Day 0 vs Day 22
Secondary outcome [3] 3049 0
Insulin sensitivity as measured by iv glucose tolerance test
Timepoint [3] 3049 0
Day 0 vs Day 22
Secondary outcome [4] 3050 0
Self monitored blood glucose recordings
Timepoint [4] 3050 0
During the 4 days of dexamethasone treatment

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
Minimum age
30 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
via computer
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1379 0
Commercial sector/Industry
Name [1] 1379 0
Glaxo Smith Kline
Country [1] 1379 0
Primary sponsor type
Individual
Name
Dr Warrick Inder
Address
Country
Secondary sponsor category [1] 1214 0
Individual
Name [1] 1214 0
Dr Christina Jang
Address [1] 1214 0
Country [1] 1214 0
Secondary sponsor category [2] 1215 0
Commercial sector/Industry
Name [2] 1215 0
Glaxo Smith Kline
Address [2] 1215 0
Country [2] 1215 0

Ethics approval
Ethics application status
Not yet submitted

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36174 0
Address 36174 0
Country 36174 0
Phone 36174 0
Fax 36174 0
Email 36174 0
Contact person for public queries
Name 10226 0
Warrick Inder
Address 10226 0
Department of Endocrinology
St Vincent's Hospital
41 Victoria Parade
Fitzroy VIC 3065
Country 10226 0
Australia
Phone 10226 0
+61 3 92882211
Fax 10226 0
+61 3 92882581
Email 10226 0
winder@medstv.unimelb.edu.au
Contact person for scientific queries
Name 1154 0
Dr Christina Jang
Address 1154 0
Department of Endocrinology
St Vincent's Hospital
41 Victoria Parade
Fitzroy VIC 3065
Country 1154 0
Australia
Phone 1154 0
+61 3 92883574
Fax 1154 0
+61 3 92883590
Email 1154 0
christina.jang@svhm.org.au

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.