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

Coronary Artery Disease Progression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03943459
• Other study ID #: 408720/2018-2
• Status: Recruiting
• Phase: Phase 3
• Start date: August 2, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: October 2019
• Source: InCor Heart Institute
• Contact: Antonio P Mansur, PhD
• Phone: +551126615387
• Email: apmansur[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Disease Progression
• Coronary Disease
• Disease Progression
• Myocardial Ischemia

Intervention

Drug:
• Quercetin
Quercetin 250 mg BID

Locations

Country	Name	City	State
Brazil	INCOR - Heart Institute	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
InCor Heart Institute

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sirtuin-1	serum concentration of sirtuin-1	60 days
Primary	Soluble receptor for advanced glycation end products	serum concentration of soluble receptor for advanced glycation end products	60 days