Effect of Fenofibrate on Endothelial Dysfunction and Oxidative Stress in patients with Type 2 Diabetes Mellitus: an open label study

Phase 4

Active, not recruiting

• Conditions: type 2 diabetes mellitus; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12612000734864
• Lead Sponsor: ita Cristina

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

patients with type 2 diabetes
treated with metformin monotherapy
without previous diagnosis of dyslipidemia and/or use of lipid-lowering medication

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).[8 weeks]

Secondary Outcome Measures

Name	Time	Method
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)[8 weeks];the effect of fenofibrate treatment on flow mediated dilation[8 weeks]