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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-02

Study Completion Date

2022-06-30

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.

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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.

Conditions

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Coronary Artery Disease Progression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

double-blind

Study Groups

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Control

20 Patients on placebo

Group Type NO_INTERVENTION

No interventions assigned to this group

Atorvastatin

20 patients treated with atorvastatin 80 mg/day

Group Type NO_INTERVENTION

No interventions assigned to this group

Quercetin

20 patients treated with quercetin 500 mg/day

Group Type EXPERIMENTAL

Quercetin

Intervention Type DRUG

Quercetin 250 mg BID

Interventions

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Quercetin

Quercetin 250 mg BID

Intervention Type DRUG

Other Intervention Names

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Atorvastatin

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

Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No