Sirtuin-1 and Advanced Glycation End-products in Postmenopausal Women With Coronary Disease

Study Overview
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Brief Summary
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Higher consumption of fruits and vegetables promote greater availability of phenolic compounds and these compounds were associated with vascular health. Quercetin, a phenolic compound, is the most abundant natural antioxidant belonging to the group of flavonoids. Quercetin improved lipoprotein metabolism, had antioxidant capacity, produced vasodilating substances in the vascular endothelium and reduced platelet aggregability. Likewise, statins are medications known to reduce cardiovascular events in women with coronary disease by reducing serum LDL-cholesterol. Therefore, a number of metabolic pathways are responsible for vascular health. The serum concentration and gene expression of sirtuin 1 (Sirt1) and RAGE soluble (sRAGE) are directly associated with vascular protection. This study will analyse the influence of atorvastatin and quercetin on serum concentrations and gene expression of Sirt1 and sRAGE in postmenopausal women with stable coronary artery disease.

Detailed Description
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Higher consumption of fruits and vegetables promote greater availability of phenolic compounds and these compounds were associated with vascular health. Quercetin, a phenolic compound, is the most abundant natural antioxidant belonging to the group of flavonoids. Quercetin improved lipoprotein metabolism, had antioxidant capacity, produced vasodilating substances in the vascular endothelium and reduced platelet aggregability. Likewise, statins are medications known to reduce cardiovascular events in women with coronary artery disease (CAD) by reducing serum LDL-cholesterol. Therefore, a number of metabolic pathways are responsible for vascular health. The serum concentration and gene expression of sirtuin 1 (Sirt1) and RAGE soluble (sRAGE) are directly associated with vascular protection. This study will analyse the influence of atorvastatin and quercetin on serum concentrations and gene expression of Sirt1 and sRAGE in postmenopausal women with stable coronary artery disease and also the correlation between the changes in serum concentration of Sirt1 and sRAGE and the changes in lipid profile, inflammatory biomarkers and sex hormones in response to these drugs. This is a 60-day randomized, double blind, placebo-controlled study in 60 postmenopausal women with CAD, divided into three groups with 20 women each: Group 1 - Quercetin (500 mg / day); Group 2 - atorvastatin (80 mg / day): Group 3 - control.

Official Title
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Serum Concentration and Gene Expression of Sirtuin-1 and Advanced Glycation End-products in Postmenopausal Women With Atherosclerotic Coronary Disease After Administration of Atorvastatin and Supplementation With Quercetin: Randomized Trial

Conditions
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Coronary Artery Disease Progression

Intervention / Treatment
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* Drug: Quercetin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: postmenopausal women, angiographic documented coronary artery disease, stable coronary artery disease Exclusion Criteria: BMI <18,1 Kg/m2, smoking, hypo or hyperthyroidism, rheumatic disease, use of alcohol, hepatic failure, renal failure hormone replacement therapy use of insulin

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

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 |
| --- | --- |
| No Intervention: Control<br>20 Patients on placebo | |
| No Intervention: Atorvastatin<br>20 patients treated with atorvastatin 80 mg/day | |
| Experimental: Quercetin<br>20 patients treated with quercetin 500 mg/day | Drug: Quercetin<br>* Quercetin 250 mg BID<br>* Other names: Atorvastatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sirtuin-1 | serum concentration of sirtuin-1 | 60 days | 
| Soluble receptor for advanced glycation end products | serum concentration of soluble receptor for advanced glycation end products | 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery disease, sirtuins, Receptor for Advanced Glycation End Products, women, quercetin, atorvastatin