Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000313538
Ethics application status
Approved
Date submitted
18/07/2006
Date registered
20/07/2006
Date last updated
20/07/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
THE EFFECT OF ROSIGLITAZONE ON OXIDATIVE STRESS AND INSULIN RESISTANCE IN OVERWEIGHT INDIVIDUALS
Scientific title
THE EFFECT OF ROSIGLITAZONE ON OXIDATIVE STRESS AND INSULIN RESISTANCE IN OVERWEIGHT INDIVIDUALS
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 1284 0
Condition category
Condition code
Diet and Nutrition 1371 1371 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Rosiglitazone 4mg orally per day for 6 months.
Intervention code [1] 1211 0
Treatment: Drugs
Comparator / control treatment
Placebo - identically matching capsule.
Control group
Placebo

Outcomes
Primary outcome [1] 1874 0
Oxidative stress markers
Timepoint [1] 1874 0
At 0, 3 and 6 months
Primary outcome [2] 1875 0
Insulin Resistance
Timepoint [2] 1875 0
At 0, 3 and 6 months
Secondary outcome [1] 3309 0
Inflammatory markers
Timepoint [1] 3309 0
0, 3 and 6 months
Secondary outcome [2] 3310 0
Liver function
Timepoint [2] 3310 0
0, 3 and 6 months

Eligibility
Key inclusion criteria
Healthy individuals with BMI > 27 kg/m2.
Minimum age
30 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Type 2 diabetes or known cardiovascular disease. Lipid lowering therapy, anti-inflammatory drugs, steroids. Recent surgery. Smoking.

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)
only one investigator privy to allocation and had no direct contact with participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 380 0
New Zealand
State/province [1] 380 0

Funding & Sponsors
Funding source category [1] 1506 0
Self funded/Unfunded
Name [1] 1506 0
Principal Investigator's research funds
Country [1] 1506 0
Primary sponsor type
Individual
Name
A/Prof PJ Manning
Address
Country
Secondary sponsor category [1] 1323 0
None
Name [1] 1323 0
nil
Address [1] 1323 0
Country [1] 1323 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2927 0
Dunedin Hospital-Otago Ethics Committee
Ethics committee address [1] 2927 0
PO Box 5849, Dunedin, New Zealand
Ethics committee country [1] 2927 0
New Zealand
Date submitted for ethics approval [1] 2927 0
Approval date [1] 2927 0
19/03/2003
Ethics approval number [1] 2927 0
02/11/113

Summary
Brief summary
This study is to determine whether the drug rosiglitazone, commonly used for people with diabetes, when used in people who are overweight reduces the levels of markers of oxidative stress and improves the action of insulin. If this was the case then this medication could potentially be considered for trials aimed at diabetes prevention. This study will specifically look at the role of this drug in people with a body mass index (weight in relation to a persons height) of >27kg/m2 (overweight). Participants will be divided in to 2 groups, one will receive the active drug and the other a placebo. At the end of the study a comparison will be made of the effectiveness of the drug compared to the placebo.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35801 0
Address 35801 0
Country 35801 0
Phone 35801 0
Fax 35801 0
Email 35801 0
Contact person for public queries
Name 10400 0
A/Prof Patrick Manning
Address 10400 0
Department of Endocrinology
Dunedin Hospital
201 Great King Street
Dunedin
Country 10400 0
New Zealand
Phone 10400 0
64 3 474 0999
Fax 10400 0
Email 10400 0
[email protected]
Contact person for scientific queries
Name 1328 0
A/Prof Patrick Manning
Address 1328 0
201 Great King Street
Dunedin
Country 1328 0
New Zealand
Phone 1328 0
64 3 474 0999
Fax 1328 0
Email 1328 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.