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

Primary Purpose

Coronary Artery Disease Progression

Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Quercetin
Sponsored by
InCor Heart Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease Progression focused on measuring coronary artery disease, sirtuins, Receptor for Advanced Glycation End Products, women, quercetin, atorvastatin

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • INCOR - Heart InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

No Intervention

Experimental

Arm Label

Control

Atorvastatin

Quercetin

Arm Description

20 Patients on placebo

20 patients treated with atorvastatin 80 mg/day

20 patients treated with quercetin 500 mg/day

Outcomes

Primary Outcome Measures

Sirtuin-1
serum concentration of sirtuin-1
Soluble receptor for advanced glycation end products
serum concentration of soluble receptor for advanced glycation end products

Secondary Outcome Measures

Full Information

First Posted
May 7, 2019
Last Updated
October 2, 2019
Sponsor
InCor Heart Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03943459
Brief Title
Sirtuin-1 and Advanced Glycation End-products in Postmenopausal Women With Coronary Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 2, 2019 (Actual)
Primary Completion Date
April 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
InCor Heart Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease Progression
Keywords
coronary artery disease, sirtuins, Receptor for Advanced Glycation End Products, women, quercetin, atorvastatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
double-blind
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
20 Patients on placebo
Arm Title
Atorvastatin
Arm Type
No Intervention
Arm Description
20 patients treated with atorvastatin 80 mg/day
Arm Title
Quercetin
Arm Type
Experimental
Arm Description
20 patients treated with quercetin 500 mg/day
Intervention Type
Drug
Intervention Name(s)
Quercetin
Other Intervention Name(s)
Atorvastatin
Intervention Description
Quercetin 250 mg BID
Primary Outcome Measure Information:
Title
Sirtuin-1
Description
serum concentration of sirtuin-1
Time Frame
60 days
Title
Soluble receptor for advanced glycation end products
Description
serum concentration of soluble receptor for advanced glycation end products
Time Frame
60 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio P Mansur, PhD
Phone
+551126615387
Email
apmansur@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
José R Oliveira
Phone
+551126615387
Email
jrafaelno@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio P Mansur, PhD
Organizational Affiliation
InCor Heart Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
INCOR - Heart Institute
City
São Paulo
ZIP/Postal Code
05403-900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio P Mansur, PhD
Phone
+551126615387
Email
apmansur@usp.br
First Name & Middle Initial & Last Name & Degree
Antônio de Pádua Mansur, PHD
First Name & Middle Initial & Last Name & Degree
José Rafael O Nascimento

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
It is not yet known if there will be a plan to make IPD available.

Learn more about this trial

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

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