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出境医 / 临床实验 / Sirtuin-1 and Advanced Glycation End-products in Postmenopausal Women With Coronary Disease
Sirtuin-1 and Advanced Glycation End-products in Postmenopausal Women With Coronary Disease
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 (Clinical Trial) |
| Estimated 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 : | August 2, 2019 |
| Estimated Primary Completion Date : | April 30, 2022 |
| Estimated Study Completion Date : | June 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 Name: Atorvastatin
|
Outcome Measures
Primary Outcome Measures :
- Sirtuin-1 [ Time Frame: 60 days ]serum concentration of sirtuin-1
- 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 Years 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 | Recruiting |
| São Paulo, Brazil, 05403-900 | |
| Contact: Antonio P Mansur, PhD +551126615387 apmansur@usp.br | |
| Principal Investigator: Antônio de Pádua Mansur, PHD | |
| Sub-Investigator: José Rafael O Nascimento | |
Sponsors and Collaborators
InCor Heart Institute
Investigators
| Principal Investigator: | Antonio P Mansur, PhD | InCor Heart Institute |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 7, 2019 | ||||||||
| First Posted Date ICMJE | May 9, 2019 | ||||||||
| Last Update Posted Date | October 4, 2019 | ||||||||
| Actual Study Start Date ICMJE | August 2, 2019 | ||||||||
| Estimated Primary Completion Date | April 30, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
|
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Sirtuin-1 and Advanced Glycation End-products in Postmenopausal Women With Coronary Disease | ||||||||
| Official Title ICMJE | 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 | ||||||||
| 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. | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Masking Description: double-blind Primary Purpose: Treatment
|
||||||||
| Condition ICMJE | Coronary Artery Disease Progression | ||||||||
| Intervention ICMJE | Drug: Quercetin
Quercetin 250 mg BID
Other Name: Atorvastatin
|
||||||||
| Study Arms ICMJE |
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
60 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | June 30, 2022 | ||||||||
| Estimated Primary Completion Date | April 30, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Sex/Gender ICMJE |
|
||||||||
| Ages ICMJE | 50 Years to 70 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Listed Location Countries ICMJE | Brazil | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03943459 | ||||||||
| Other Study ID Numbers ICMJE | 408720/2018-2 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement ICMJE |
|
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| Responsible Party | ANTONIO DE PADUA MANSUR, InCor Heart Institute | ||||||||
| Study Sponsor ICMJE | InCor Heart Institute | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
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| PRS Account | InCor Heart Institute | ||||||||
| Verification Date | October 2019 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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