A Randomised, Double-Blind, Placebo-Controlled Study Assessing the Effect of Fenofibrate, Coenzyme Q10 and Their co-Administration on Ventricular Diastolic Function in Patients With Type 2 Diabetes

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00703482

Enrollment

278

Registered

2008-06-23

Start date

2003-05-31

Completion date

2004-09-30

Last updated

2008-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients With Type 2 Diabetes

Keywords

Ventricular diastolic Function, Diabetes

Brief summary

The purpose of this study was to study the effect of different combinations of fenofibrate and coenzyme Q10 on ventricular diastolic function in patients with Type II diabetes

Interventions

DRUGFenofibrate/CoQ10

Fenofibrate pbo/CoQ10 placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to 79 Years

Healthy volunteers

Inclusion criteria

* Men or women aged from 40 to 79 years * Patients with pre-existing T2DM * HbA1C \<9% * Written informed consent

Exclusion criteria

* unable to comply with the protocol, Likely to leave the trial before completion * having participated in an another trial 3à days before V1 * Pregnant or childbearing potential not using birth control method * Type 1 diabetic patients, T2Dm insulin therapy Patients with one of the following pathology: * with muscular disorders known or increase CK , or hepatic deficiency or transaminase increase * with symptomatic gall-bladder disease or/and renal insufficiency * with abnormal thyroid function * with proliferative retinopathy * with recent cardiovascular event, uncontrolled hypertension * with known chronic alcohol intake * with other severe pathology * with TC\>= 7.0 mmol/L and/or TG\>= 4mmol/L at V1 * Patients treated with Warfarin * Patients with specific ECG dysfunction

Design outcomes

Primary

Measure	Time frame
Evolution of the E'/E septal ratio	End of study (V6)

Secondary

Measure	Time frame
Evolution of the Left atrium and right atrium volumes	End of study (V6)
Evolution of the Left and right sizes	End of study (V6)
Evolution of the LVEDD and LVESD	End of study (V6)
Evolution of the LVEDV and LVESV	End of study (V6)
Severity of the LVDD	End of study (V6)
Evolution of the LV ejection fraction	End of study (V6)
Evolution of the IVRT	End of study (V6)
Evolution of the tissue Doppler E'/A' ratio	End of study (V6)
Evolution of the PV doppler parameters	End of study (V6)
Evolution of the LV mass	End of study (V6)

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026