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

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03943459
Enrollment
60
Registered
2019-05-09
Start date
2019-08-02
Completion date
2022-06-30
Last updated
2019-10-04

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

Conditions

Coronary Artery Disease Progression

Keywords

coronary artery disease, sirtuins, Receptor for Advanced Glycation End Products, women, quercetin, atorvastatin

Brief summary

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

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.

Interventions

DRUGQuercetin

Quercetin 250 mg BID

Sponsors

InCor Heart Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

double-blind

Eligibility

Sex/Gender
FEMALE
Age
50 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Sirtuin-160 daysserum concentration of sirtuin-1
Soluble receptor for advanced glycation end products60 daysserum concentration of soluble receptor for advanced glycation end products

Countries

Brazil

Contacts

Primary ContactAntonio P Mansur, PhD
apmansur@yahoo.com+551126615387
Backup ContactJosé R Oliveira
jrafaelno@gmail.com+551126615387

Outcome results

None listed

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