Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000734864
Ethics application status
Approved
Date submitted
9/07/2012
Date registered
10/07/2012
Date last updated
11/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of Fenofibrate on Endothelial Dysfunction and Oxidative Stress in patients with Type 2 Diabetes Mellitus: an open label study
Scientific title
Effect of Fenofibrate on Endothelial Dysfunction and Oxidative Stress in patients with Type 2 Diabetes Mellitus: an open label study
Secondary ID [1] 280798 0
Nil
Universal Trial Number (UTN)
U1111-1132-5269
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
type 2 diabetes mellitus 286859 0
Condition category
Condition code
Metabolic and Endocrine 287180 287180 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
to investigate the role of fenofibrate on plasma myeloperoxidase concentrations in patients with type 2 diabetes.
Starting from visit 1, each subject received daily treatment with oral tablets of fenofibrate 160 mg once daily for 8 weeks.
Intervention code [1] 285226 0
Treatment: Drugs
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287476 0
the effect of fenofibrate treatment on plasma myeloperoxidase measured in plasma (EDTA) using commercial enzyme-linked immunosorbent assay kits for quantitative detection: plasma MPO (DRG International, Inc, USA).
Timepoint [1] 287476 0
8 weeks
Secondary outcome [1] 298252 0
the effect of fenofibrate treatment on E-selectin measured in plasma (EDTA) using commercial enzyme-linked immunosorbent assay kits for quantitative detection: sE-selectin (DRG Diagnostics GmbH, Germany)
Timepoint [1] 298252 0
8 weeks
Secondary outcome [2] 298253 0
the effect of fenofibrate treatment on flow mediated dilation
Timepoint [2] 298253 0
8 weeks

Eligibility
Key inclusion criteria
patients with type 2 diabetes
treated with metformin monotherapy
without previous diagnosis of dyslipidemia and/or use of lipid-lowering medication
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
type 1 diabetes mellitus
treatment with other hypoglycaemic drugs in the past 3 months,
recent acute cardiovascular event within 3 months,
uncontrolled endocrine or metabolic diseases
chronic kidney disease
persistent elevation of alanine aminotransferase, aspartate aminotransferase,
history of alcohol abuse,
previous treatment with any lipid-lowering drugs,
changes in hypoglycaemic or antihypertensive treatment during the last 3 months

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



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
15/05/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
27
Accrual to date
Final
Recruitment outside Australia
Country [1] 4397 0
Romania
State/province [1] 4397 0

Funding & Sponsors
Funding source category [1] 285594 0
Self funded/Unfunded
Name [1] 285594 0
Country [1] 285594 0
Romania
Primary sponsor type
Individual
Name
Nita Cristina
Address
2-4 Clinicilor Street
400006
Cluj Napoca
Country
Romania
Secondary sponsor category [1] 284423 0
None
Name [1] 284423 0
Address [1] 284423 0
Country [1] 284423 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287596 0
Ethics committee of the "iuliu Hatieganu" University of Medicine and Pharmacy
Ethics committee address [1] 287596 0
Ethics committee country [1] 287596 0
Romania
Date submitted for ethics approval [1] 287596 0
20/08/2010
Approval date [1] 287596 0
26/10/2010
Ethics approval number [1] 287596 0
180/26-10-2010

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

Contacts
Principal investigator
Name 34409 0
Address 34409 0
Country 34409 0
Phone 34409 0
Fax 34409 0
Email 34409 0
Contact person for public queries
Name 17656 0
Cristina Nita
Address 17656 0
2-4 Clinicilor street
Cluj Napoca
400006
Country 17656 0
Romania
Phone 17656 0
+40744549928
Fax 17656 0
Email 17656 0
[email protected]
Contact person for scientific queries
Name 8584 0
Cristina Nita
Address 8584 0
2-4 Clinicilor street
Cluj Napoca
400006
Country 8584 0
Romania
Phone 8584 0
+40744549928
Fax 8584 0
Email 8584 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.