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

• Sponsor: InCor Heart Institute (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03943459
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 34.9
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Progression	Drug: Quercetin	Phase 3

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Masking Description: double-blind
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Aug 2, 2019
• Anticipated Primary Completion Date: Apr 30, 2022
• Anticipated Study Completion Date: Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control 20 Patients on placebo
No Intervention: Atorvastatin 20 patients treated with atorvastatin 80 mg/day
Experimental: Quercetin 20 patients treated with quercetin 500 mg/day	Drug: Quercetin; Quercetin 250 mg BID; Other Names: Atorvastatin

Outcome Measures

Primary Outcome Measures

1. Sirtuin-1 [60 days]

   serum concentration of sirtuin-1

2. Soluble receptor for advanced glycation end products [60 days]

   serum concentration of soluble receptor for advanced glycation end products

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	INCOR - Heart Institute	São Paulo		Brazil	05403-900

Sponsors and Collaborators

• InCor Heart Institute

Investigators

• Principal Investigator: Antonio P Mansur, PhD, InCor Heart Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ANTONIO DE PADUA MANSUR, Associate Professor, InCor Heart Institute
• ClinicalTrials.gov Identifier: NCT03943459
• Other Study ID Numbers: 408720/2018-2
• First Posted: May 9, 2019
• Last Update Posted: Oct 4, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by ANTONIO DE PADUA MANSUR, Associate Professor, InCor Heart Institute: coronary artery disease; sirtuins; Receptor for Advanced Glycation End Products; women; quercetin; atorvastatin
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Disease Progression; Atorvastatin; Quercetin

Study Results

No Results Posted as of Oct 4, 2019