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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/23/2021.

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

Clinicaltrials.gov identifier NCT03943459

Recruitment Status Recruiting

First Posted May 9, 2019

Last update posted October 4, 2019

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:Coronary Artery Disease Progression
  • Intervention/Treatment: Drug: Quercetin
  • Phase: 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
  • Estimated Enrollment: 60 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Investigator)
  • 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: August 2019
  • Estimated Primary Completion Date: April 2022
  • Estimated Study Completion Date: June 2022
Arms and interventions
Arm Intervention/treatment
Experimental: Quercetin
20 patients treated with quercetin 500 mg/day
Drug: Quercetin
Quercetin 250 mg BID
Outcome Measures
  • Primary Outcome Measures: 1. Sirtuin-1 [ Time Frame: 60 days ]
    serum concentration of sirtuin-1
  • 2. Soluble receptor for advanced glycation end products [ Time Frame: 60 days ]
    serum concentration of soluble receptor for advanced glycation end products
Eligibility Criteria
  • Ages Eligible for Study: 50 to 70 Years (Adult, Older Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: No
Criteria

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
Contacts

Contact: Antonio P Mansur, PhD +551126615387 apmansur@yahoo.com

Contact: José R Oliveira +551126615387 jrafaelno@gmail.com

Locations

Brazil
INCOR - Heart Institute
São Paulo

Sponsors and Collaborators

InCor Heart Institute

Investigators

Principal Investigator: Antonio P Mansur, PhD InCor Heart Institute

More Information
  • Responsible Party: InCor Heart Institute
  • ClinicalTrials.gov Identifier: NCT03943459 History of Changes
  • Other Study ID Numbers: 408720/2018-2
  • First Posted: May 9, 2019 Key Record Dates
  • Last Update Posted: October 4, 2019
  • Last Verified: October 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Plan Description: It is not yet known if there will be a plan to make IPD available.
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by InCor Heart Institute: women
    coronary artery disease
    sirtuins
    Receptor for Advanced Glycation End Products
    quercetin
    atorvastatin
  • Additional relevant MeSH terms: Coronary Artery Disease
    Myocardial Ischemia
    Coronary Disease
    Disease Progression