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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Patients With Type 2 Diabetes

Intervention / Treatment
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* Drug: Fenofibrate/CoQ10
* Drug: Fenofibrate/CoQ10
* Drug: Fenofibrate/CoQ10
* Drug: Fenofibrate/CoQ10
* Drug: Fenofibrate/CoQ10
* Drug: Fenofibrate/CoQ10
* Drug: Fenofibrate/CoQ10


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: Fenofibrate/CoQ10<br>* Fenofibrate pbo/CoQ10 placebo<br>Drug: Fenofibrate/CoQ10<br>* Fenofibrate 160mg/CoQ10 placebo<br>|
| Active Comparator: 2<br> | Drug: Fenofibrate/CoQ10<br>* Fenofibrate pbo/CoQ10 200 mg<br>|
| Active Comparator: 3<br> | Drug: Fenofibrate/CoQ10<br>* Fenofibrate 160mg/CoQ10 placebo<br>|
| Experimental: 4<br> | Drug: Fenofibrate/CoQ10<br>* Fenofibrate 80/CoQ10 100 mg<br>|
| Experimental: 5<br> | Drug: Fenofibrate/CoQ10<br>* Fenofibrate 160mg/CoQ10 100 mg<br>|
| Experimental: 6<br> | Drug: Fenofibrate/CoQ10<br>* Fenofibrate 80 /CoQ10 200 mg<br>|
| Experimental: 7<br> | Drug: Fenofibrate/CoQ10<br>* Fenofibrate 160mg/CoQ10 200 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of the E'/E septal ratio |  | End of study (V6) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of the LVDD |  | End of study (V6) | 
| 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) | 
| Evolution of the LV mass |  | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ventricular diastolic Function, Diabetes