Curcumin's Effect on Diabetic Patients With Atherosclerotic Cardiovascular Risk

Phase 2

Recruiting

• Conditions: Dyslipidemias; Diabetes Mellitus, Type 2; Hypertension
• Interventions: Dietary Supplement: Puritans Pride Turmeric curcumin® 500 mg

• Registration Number: NCT05753436
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study First Submitted: 2023-01-31
• Study First Submitted QC: 2023-03-01
• Study First Posted: 2023-03-03
• Study Start: 2023-07-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-09
• Last Update Posted: 2024-02-13
• Primary Completion: 2024-03
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1, Curcumin group	Puritans Pride Turmeric curcumin® 500 mg	Group 1, Curcumin group (n=36): Patients will receive conventional treatment co-administrated with Turmeric Curcumin 500 mg thrice daily for 14 weeks.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)
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

Trial Locations

Locations (1)

Demerdash Hospital, Faculty of Medicine, Ain Shams University; 🇪🇬 Cairo, Egypt