Diabetes Mellitus, Type 2, Dyslipidemias, Hypertension
Conditions
Keywords
Diabetes Mellitus, ASCVD Risk, Curcumin, Inflammation, Oxidative stress, Diabetes complication
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.
Interventions
DIETARY_SUPPLEMENTPuritans Pride Turmeric curcumin® 500 mg
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.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate | Change from Baseline Heart Rate at 14 weeks | Pulse in bpm |
| (Atherosclerotic cardiovascular diseases risk score) Low-risk (<5%) Borderline risk (5% to 7.4%) Intermediate risk (7.5% to 19.9%) High risk (≥20%) | Change from Baseline ASCVD risk scoring at 14 weeks | 10 year ASCVD risk calculation by using Pooled cohort equations |
| Blood Glucose Level | Change from Baseline Blood Glucose Level at 14 weeks | Fasting blood glucose (FBG) in mg/dl , Hemoglobin A1c (HbA1c) in percentage |
| Lipid Profile | Change from Baseline Lipid profile at 14 weeks | Serum sample to determine ( Triglyceride level , LDL ,HDL ,Total cholesterol ) in mg/dl |
| Blood Pressure | Change from Baseline Blood Pressure at 14 weeks | (SBP and DBP) in mmHg by using Sphygmomanometer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of Malondialdehyde (MDA) | Change from Baseline MDA concentration at 14 weeks | Serum sample to determine MDA (Oxidative stress marker) |
| International normalized ratio | Change from Baseline INR level at 14 weeks | Blood sample to determine INR level for those patients receiving anticoagulants |
| Serum Ferritin | Change from Baseline Ferritin concentration at 14 weeks | Serum Ferritin for those patients who are suspected to be anemic or are anemic. |
| Concentration of Tumor necrosis factor alpha ( TNF-alpha) | Change from Baseline TNF-alpha concentration at 14 weeks | Serum sample to determine TNF alpha (Inflammatory biomarker) |
Countries
Egypt
Outcome results
None listed