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
13 Emil Isac street
400023 Cluj Napoca
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
Fenofibrate is a drug largely used in patients with type 2 diabetes and mixed dyslipidemia due to its effects of reducing triglycerides concentration and enhancing HDL cholesterol levels. Also there are a lot of evidences regarding the pleiotropic effects of fenofibrate such as: decrease in systemic inflammation and monocyte cytokine release, improvement in insulin sensitivity and hemostasis, important antioxidant, antithrombotic and antiplatelet activities.
In light of the foregoing data, the main purpose of this study was to investigate the role of fenofibrate on plasma MPO concentrations in patients with type 2 diabetes
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
cnita@umfcluj.ro
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
cnita@umfcluj.ro

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What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

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