Curcumin's Effect on Diabetic Patients With Atherosclerotic Cardiovascular Risk

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Evaluation of the Effect of Curcumin Administration on the Clinical Outcome of Diabetic Patients With Atherosclerotic Cardiovascular Risk

Conditions
-----------------
Diabetes Mellitus, Type 2, Dyslipidemias, Hypertension

Intervention / Treatment
-----------------
* Dietary Supplement: Puritans Pride Turmeric curcumin® 500 mg


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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1, Curcumin group<br>Group 1, Curcumin group (n=36): Patients will receive conventional treatment co-administrated with Turmeric Curcumin 500 mg thrice daily for 14 weeks. | Dietary Supplement: Puritans Pride Turmeric curcumin® 500 mg<br>* 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.<br>* Other names: Curcumin;|
| No Intervention: Group 2, Control group<br>Group 2, Control group (n= 36): Patients will receive conventional therapy alone for 14 weeks. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (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 | Change from Baseline ASCVD risk scoring at 14 weeks | 
| Blood Glucose Level | Fasting blood glucose (FBG) in mg/dl , Hemoglobin A1c (HbA1c) in percentage | Change from Baseline Blood Glucose Level at 14 weeks | 
| Lipid Profile | Serum sample to determine ( Triglyceride level , LDL ,HDL ,Total cholesterol ) in mg/dl | Change from Baseline Lipid profile at 14 weeks | 
| Blood Pressure | (SBP and DBP) in mmHg by using Sphygmomanometer | Change from Baseline Blood Pressure at 14 weeks | 
| Heart Rate | Pulse in bpm | Change from Baseline Heart Rate at 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of Tumor necrosis factor alpha ( TNF-alpha) | Serum sample to determine TNF alpha (Inflammatory biomarker) | Change from Baseline TNF-alpha concentration at 14 weeks | 
| Concentration of Malondialdehyde (MDA) | Serum sample to determine MDA (Oxidative stress marker) | Change from Baseline MDA concentration at 14 weeks | 
| International normalized ratio | Blood sample to determine INR level for those patients receiving anticoagulants | Change from Baseline INR level at 14 weeks | 
| Serum Ferritin | Serum Ferritin for those patients who are suspected to be anemic or are anemic. | Change from Baseline Ferritin concentration at 14 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Mellitus, ASCVD Risk, Curcumin, Inflammation, Oxidative stress, Diabetes complication