ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12610000671066

Ethics application status

Not yet submitted

Date submitted

16/08/2010

Date registered

16/08/2010

Date last updated

16/08/2010

Type of registration

Prospectively registered

Titles & IDs

Public title

Fenofibrate effects on endothelial progenitor cell (EPC) number and function

Scientific title

Fenofibrate effects on endothelial progenitor cell (EPC) number and function in patients with recent diagnosis of type 2 diabetes mellitus (T2DM).

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Type 2 Diabetes mellitus

Hypercholesterolemia/dyslipidemia

Condition category

Condition code

Cardiovascular

Diseases of the vasculature and circulation including the lymphatic system

Metabolic and Endocrine

Diabetes

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Commencement of fenofibrate 145mg tablets orally as a single dose daily for 6 weeks. At the end of the 6 week period, half the subjects selected randomly will receive additional atorvastatin 40mg daily taken orally and the other half will continue with fenofibrate 145mg only for a further 6 weeks . At the end of the 12 week treatment period, all intervention treatment will be ceased and subjects analysed 6 weeks later.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Patients on treatment will act as controls with assesment of EPC number/function at baseline, and subsequent comparison of patients on fenofibrate only versus combination of fenofibrate plus atorvatstain.

Control group

Active

Outcomes

Primary outcome [1]

Change in EPC number using flow cytometric analysis.

Timepoint [1]

Assessments done at baseline, 6, 12 and at 18 weeks.

Primary outcome [2]

EPC function using standardized colony forming unit assays and by in vitro angiogenesis assays using Matrigel. Serum angiogenic factors will be quantified by Enzyme Linked Immunosorbent Assay (ELISA).

Timepoint [2]

Assessments done at baseline, 6, 12 and at 18 weeks.

Secondary outcome [1]

Nil

Timepoint [1]

N/A

Eligibility

Key inclusion criteria

1)Recently diagnosed type 2 diabetes mellitus in adults.
2) No previous recent exposure to or any current definite indication for statins or fibrates

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1) Age less than 18 years
2) Pregnant women(based on urine Beta Human Choriogonadotrophin test (HCG))
3) Cognitively impaired, homeless people or others considered unlikely to comply.
4) Acute myocardial infarction within the last 3 months
5) Anemia with Hemoglobin < 110 mg/dl
6) Significant renal impairment (estimated Glomerular Filtration Rate<60 ml/min/1.73m^2)
7) Active liver disease
8) Clinical gallbladder disease
9)Known hypersensitivity to statin or fibrate therapy
10) Severe hypertriglyceridaemia and/or pancreatitis requiring fibrate therapy

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

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/10/2010

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

University

Name [1]

National Health and Medical Research Council, Clinical Trials Centre, University of Sydney

Address [1]

Locked Bag 77, Camperdown NSW 1450

Country [1]

Australia

Primary sponsor type

Individual

Name

Prof Anthony Keech

Address

Locked Bag 77, Camperdown NSW 1450

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Individual

Name [1]

Dr Martin Ng

Address [1]

Heart Research Institute, 7 Eliza Street Newtown, NSW 2042

Country [1]

Australia

Other collaborator category [2]

Individual

Name [2]

Prof Roland Stocker

Address [2]

Room 253, Medical Foundation Building, K25, 92-94 Parramatta Rd, Camperdown, NSW 2050

Country [2]

Australia

Other collaborator category [3]

Individual

Name [3]

Dr Kushwin Rajamani

Address [3]

Locked Bag 77, Camperdown NSW 1450

Country [3]

Australia

Other collaborator category [4]

Individual

Name [4]

Dr Linda Hoffman

Address [4]

Room 154, Medical Foundation Building, K25, 92-94 Parramatta Rd, Camperdown, NSW 2050

Country [4]

Australia

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

30/06/2010

Approval date [1]

Ethics approval number [1]

X10-0192

Summary

Brief summary

BACKGROUND AND SCIENTIFIC BASIS
Coronary artery disease is an important cause of morbidity and mortality worldwide. Although much is known about the mechanism of myocardial infarction and its associated risk factors, many patients develop myocardial infarction in the absence of known risk factors. Two possible explanations for this are impaired angiogenesis (new blood vessel formation) and impaired endothelial (blood vessel lining) reparative processes in this group of patients. Endothelial progenitor cells (EPC) are thought to be involved in these two processes by: 1) incorporating into new vessels, or 2) coordinating the reparative process.

Fenofibrate is a lipid-lowering agent, used in the setting of hypercholesterolemia, particularly among patients with coronary artery disease and diabetes. It has well documented beneficial effects by reducing myocardial infarction. In practice, it is commonly used when patients are intolerant of statins (another cholesterol lowering agent), or in combination with statins.  Interest in fenofibrate has increased with recent observations of reduced diabetic microvascular complications. 

Little is known about EPCs and their function. It has been recently shown that EPCs derived from bone marrow circulate in the peripheral blood and can facilitate the formation of new blood vessels in tissues that are not getting enough blood supply, thereby helping to increase the blood supply to the affected tissue (Asahara T et al Science. 1997;275:964, Urbich C. Circ Res. 2004;95:343). Moreover, patients with coronary artery disease who have high blood levels of EPCs have a better prognosis than those with low EPC levels, possibly due to the beneficial reparative effects of these cells (Werner N. N Engl J Med 2005;353:999).  It is unknown if the clinical outcomes of fenofibrate are partly related to EPC levels and function. Statins have been shown to have a positive effect on EPC number and function when used alone. Their effects in combination with fenofibrate have not been evaluated.   

HYPOTHESIS
The central hypotheses of this project are that: 1) EPC levels are increased by fenofibrate 2) EPC levels are higher in those with vascular disease, 3) Fenofibrate augments EPC differentiation and function and 4) Effects of fenofibrate on EPC s occur with and without combination statin therapy.    

AIMS
1.To determine the number of EPC s after fenofibrate   treatment. 
2.To investigate if fenofibrate augments EPC function and number. 
3.To see the additional benefit of statins on EPC number and function.  


POTENTIAL SIGNIFICANCE
 This study will be one of the preliminary studies in man, to identify if fenofibrate has a positive effect on EPCs, and provide an understanding of the clinical effects observed. This will have implications in understanding the role of EPCs in the pathogenesis of vascular diseases, as well as in the development of novel treatment strategies for reducing the impact of vascular disease and myocardial infarction.

Trial website

Nil

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Kushwin Rajamani

Address

Locked Bag 77,
Camperdown NSW 1450

Country

Australia

Phone

+61 413540679

Fax

kushwin79@yahoo.co.uk

Contact person for scientific queries

Name

Dr Kushwin Rajamani

Address

Locked Bag 77,
Camperdown NSW 1450

Country

Australia

Phone

+61 413540679

Fax

kushwin79@yahoo.co.uk

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.

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