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
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Aug 2019
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2019
CompletedFirst Posted
Study publicly available on registry
May 9, 2019
CompletedStudy Start
First participant enrolled
August 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedOctober 4, 2019
October 1, 2019
2.7 years
May 7, 2019
October 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Sirtuin-1
serum concentration of sirtuin-1
60 days
Soluble receptor for advanced glycation end products
serum concentration of soluble receptor for advanced glycation end products
60 days
Study Arms (3)
Control
NO INTERVENTION20 Patients on placebo
Atorvastatin
NO INTERVENTION20 patients treated with atorvastatin 80 mg/day
Quercetin
EXPERIMENTAL20 patients treated with quercetin 500 mg/day
Interventions
Eligibility Criteria
You may qualify if:
- postmenopausal women,
- angiographic documented coronary artery disease,
- stable coronary artery disease
You may not qualify if:
- BMI \<18,1 Kg/m2,
- smoking,
- hypo or hyperthyroidism,
- rheumatic disease,
- use of alcohol,
- hepatic failure,
- renal failure
- hormone replacement therapy
- use of insulin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
INCOR - Heart Institute
São Paulo, 05403-900, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Antonio P Mansur, PhD
InCor Heart Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- double-blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 7, 2019
First Posted
May 9, 2019
Study Start
August 2, 2019
Primary Completion
April 30, 2022
Study Completion
June 30, 2022
Last Updated
October 4, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share
It is not yet known if there will be a plan to make IPD available.