A Case Control Study of Resveratrol Effects in Coronary Artery Disease Patients With Metabolic Syndrome

NCT ID: NCT02137421

Last Updated: 2017-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2014-12-31

Brief Summary

The aim of this study is to explore the role of Canonical β-catenin/Wnt and forkhead box O (FOXO) pathways by means of investigating their target genes in coronary artery disease (CAD) pathogenesis and to examine the effects of resveratrol (RES) on these pathways in CAD patients.

Detailed Description

Metabolic syndrome is a constellation of cardiovascular and metabolic risk factors including obesity, insulin resistance, hypertension and dyslipidemia. Coronary artery disease (CAD) is considerably linked with these risk factors. Oxidative stress has a major role in development of atherosclerosis that is believed as the most common pathologic process underlying CAD. The up-regulated gene-expression of free radical scavenging enzymes such as manganese superoxide dismutase (MnSOD) by members of the forkhead box O (FOXO) transcription factors is considered to be one of the paramount cell defensive mechanisms against oxidative damage. It is now well recognized that β-catenin binds to FOXOs during oxidative stress and acts as the pivotal mediator in canonical Wnt signaling, so that it translocates to the nucleus and interacts with the family of transcription factors T-cell factor/lymphoid enhancer factor (TCF/LEF), to regulate the expression of Wnt target genes. Recent evidence suggested that the canonical Wnt signaling plays a profound role in regulation of lipid metabolism and glucose homeostasis. Peroxisome proliferator-activated receptor delta (PPAR-δ) is one of the Wnt target genes which is believed to be operative in cardiometabolic protection. Interestingly, it has been demonstrated that impaired Wnt signaling pathway is contributed to inflammation, foam cell formation, and endothelial dysfunction which are recognized as atherosclerosis pathogenic factors. Resveratrol (RES) (3, 4´, 5 trihydroxystilbene), a natural polyphenol with antioxidant effects can be found in red grapes and its processed drinks (e.g. red wine), peanuts, pomegranates and mulberries.Increasing body of evidence suggest a protective role for RES against CAD, however the underlying mechanisms still remain to be elucidated. We perform this study on 10 metabolic syndrome patients with three-vessel CAD and 10 sex-aged matched (men with 40-55 years old) healthy subjects as controls. The effects of RES on β-Catenin, manganese superoxide dismutase (MnSOD), and peroxisome proliferator-activated receptor delta (PPAR-δ) expression are evaluated in peripheral blood mononuclear cells (PBMCs) of participants.

Conditions

Metabolic Syndrome; Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

CAD, Metabolic syndrome .

Arm1:coronary artery disease with metabolic syndrome . Intervention:Resveratrol (3, 4´, 5 trihydroxystilbene), 50 micromolar,12hour treatment .

Each experiment repeats three times .

Group Type: EXPERIMENTAL

Resveratrol (3, 4´, 5 trihydroxystilbene)

Intervention Type: DIETARY_SUPPLEMENT

Resveratrol (RES) (3, 4´, 5 trihydroxystilbene)

Healthy subjects .

Arm2:healthy subjects Intervention:Resveratrol (3, 4´, 5 trihydroxystilbene), 50 micromolar,12hour treatment .

Each experiment repeats three times .

Group Type: EXPERIMENTAL

Resveratrol (3, 4´, 5 trihydroxystilbene)

Intervention Type: DIETARY_SUPPLEMENT

Resveratrol (RES) (3, 4´, 5 trihydroxystilbene)

Interventions

Resveratrol (3, 4´, 5 trihydroxystilbene)

Resveratrol (RES) (3, 4´, 5 trihydroxystilbene)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

-Three vessel coronary artery disease with metabolic syndrome based on WHO criteria

Exclusion Criteria

• Malignancy,
• Myocardial infarction,
• Unstable angina,
• Previous coronary intervention,
• Inflammatory diseases,
• Diabetes,
• Hypertension,
• Endocrine disorders,
• Other known chronic diseases,
• Antioxidant therapy or vitamin supplements in the previous 12 months,
• Smokers .

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Tehran University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Taghi Golmohammadi, PhD

Role: STUDY_CHAIR

Tehran University of Medical Sciences

Arash Hosseinnejad, MD-PhD

Role: STUDY_CHAIR

Tehran University of Medical Sciences

Reza Meshkani, PhD

Role: STUDY_DIRECTOR

Tehran University of Medical Sciences

Mahmoud Shirzad, MD

Role: STUDY_DIRECTOR

Tehran Heart Center,Tehran University of Medical Sciences

Mehrnoosh Shanaki Bavarsad, PhD student

Role: PRINCIPAL_INVESTIGATOR

Tehran University of Medical Sciences

Locations

Islamic Republic of Iran

Tehran, , Iran

Countries

Iran

Other Identifiers

17001-30-01-91

Identifier Type: -

Identifier Source: org_study_id