Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00408850




Registration number
NCT00408850
Ethics application status
Date submitted
6/12/2006
Date registered
7/12/2006
Date last updated
17/01/2013

Titles & IDs
Public title
Effects of Pioglitazone Treatment on Sympathetic Nervous System Function in Metabolic Syndrome Obesity
Scientific title
Mechanisms of Sympathetic Overactivity in the Metabolic Syndrome: Effects of Reversing Insulin Resistance by Drug Treatment
Secondary ID [1] 0 0
G 06M 2610
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic Syndrome 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pioglitazone
Treatment: Drugs - sugar pill

Active comparator: Pioglitazone - pioglitazone 15 mg for 6 weeks followed by 30 mg for 6 weeks

Placebo comparator: sugar pill - Placebo comparator


Treatment: Drugs: Pioglitazone
15 mg per day for 6 weeks and 30 mg per day for further 6 weeks

Treatment: Drugs: sugar pill
One capsule daily for 6 weeks followed by two capsules per day for next 6 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Sympathetic nervous system activity, measured as muscle sympathetic nervous activity and whole-body noradrenaline spillover
Timepoint [1] 0 0
12 weeks treatment
Secondary outcome [1] 0 0
Baroreflex function, adrenoceptor expression
Timepoint [1] 0 0
12 weeks treatment

Eligibility
Key inclusion criteria
* Males and females aged 45-65 years,
* non-smokers,
* HOMA index > 2.5 and
* who meet ATP III criteria for the metabolic syndrome
Minimum age
45 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of diabetes,
* previous MI, stroke, heart failure, impaired hepatic or renal function.
* Inability to cease medications which may affect study parameters.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2013
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Baker Heart Research Institute - Melbourne
Recruitment postcode(s) [1] 0 0
8008 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Baker Heart Research Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Heart Foundation, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Nora E Straznicky, PhD, MPH
Address 0 0
Baker Heart Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Nora E Straznicky, PhD, MPH
Address 0 0
Country 0 0
Phone 0 0
61 3 8532 1371
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00408850