Curcumin's Effect on Diabetic Patients With Atherosclerotic Cardiovascular Risk

Ain Shams University72 enrolled

Overview

The aim of the study is to assess the safety and efficacy of Curcumin supplementation in combination to the conventional therapy in improving the clinical outcomes, oxidative stress and inflammation in diabetic patients with risk of ASCVD.

Atherosclerotic cardiovascular disease (ASCVD) is one of the most devastating consequences of Diabetes Mellitus (DM), especially when combined with other comorbid conditions such as dyslipidemia and hypertension. To lessen the probability of ASCVD, modifying an individual's lifestyle and regulating one's lipid profile, blood pressure, and glucose levels are all beneficial approaches that decrease the risk of ASCVD occurrence. Numerous diseases, including hypertension, dyslipidemia, and diabetes mellitus, have been shown to be significantly influenced by both oxidative stress and inflammation. Curcumin is thought to regulate blood pressure, lipid profile, blood glucose levels. Moreover, It is claimed that curcumin can alleviate inflammation and oxidative stress. Curcumin is therefore suggested to have a beneficial role in lowering the risk of atherosclerotic cardiovascular diseases.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus, Type 2 Dyslipidemias Hypertension

Interventions

Puritans Pride Turmeric curcumin® 500 mgDIETARY_SUPPLEMENT

Turmeric curcumin 500 mg per oral capsule of Puritans Pride company supplement composed of Turmeric (curcuma longa) root 450mg and Turmeric extract (curcuma longa root 50mg ) standardized to contain 95%curcuminoids.It is added because of its possibility to reduce the risk of ASCVD by lowering blood pressure, lipid profile, blood glucose, inflammation, and oxidative stress.

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Adult Male or female patients aged 40 years or older 2. A calculated 10 year ASCVD risk score of 5 % or more 3. Patient previously or newly diagnosed with hypertension 4. Patient previously or newly diagnosed with dyslipidaemia 5. Patients diagnosed as Type 2 diabetes mellitus taking insulin or oral hypoglycemic agent with controlled HbA1c \< 10% 6. Willingness and ability to give informed consent. Exclusion Criteria: 1. Congenital or acquired bleeding disorders. 2. Cholelithiasis, gall bladder or biliary tract disease or other active liver diseases. 3. Pregnant or breastfeeding women. 4. Oral hypoglycemic drugs that affect cardiovascular diseases risk. 5. Patients with clinical ASCVD (myocardial infarction, stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack, or peripheral arterial disease).

Locations (1)

Demerdash Hospital, Faculty of Medicine, Ain Shams University

Cairo, Egypt

Outcomes

Primary Outcomes

(Atherosclerotic cardiovascular diseases risk score) Low-risk (<5%) Borderline risk (5% to 7.4%) Intermediate risk (7.5% to 19.9%) High risk (≥20%)

10 year ASCVD risk calculation by using Pooled cohort equations

Time frame: Change from Baseline ASCVD risk scoring at 14 weeks

Blood Glucose Level

Fasting blood glucose (FBG) in mg/dl , Hemoglobin A1c (HbA1c) in percentage

Time frame: Change from Baseline Blood Glucose Level at 14 weeks

Lipid Profile

Serum sample to determine ( Triglyceride level , LDL ,HDL ,Total cholesterol ) in mg/dl

Time frame: Change from Baseline Lipid profile at 14 weeks

Blood Pressure

(SBP and DBP) in mmHg by using Sphygmomanometer

Time frame: Change from Baseline Blood Pressure at 14 weeks

Heart Rate

Pulse in bpm

Time frame: Change from Baseline Heart Rate at 14 weeks

Secondary Outcomes

Concentration of Tumor necrosis factor alpha ( TNF-alpha)

Serum sample to determine TNF alpha (Inflammatory biomarker)

Time frame: Change from Baseline TNF-alpha concentration at 14 weeks

Concentration of Malondialdehyde (MDA)

Serum sample to determine MDA (Oxidative stress marker)

Time frame: Change from Baseline MDA concentration at 14 weeks

International normalized ratio

Data from ClinicalTrials.gov

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