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

• Conditions: Type 2 Diabetes mellitus; Hypercholesterolemia/dyslipidemia; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12610000671066
• Lead Sponsor: Prof Anthony Keech

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-08-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 22

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

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).[Assessments done at baseline, 6, 12 and at 18 weeks.];Change in EPC number using flow cytometric analysis.[Assessments done at baseline, 6, 12 and at 18 weeks.]

Secondary Outcome Measures

Name	Time	Method
il[N/A]