Curcumin's Effect on Diabetic Patients With Atherosclerotic Cardiovascular Risk

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05753436
• Other study ID #: RHDIRB2020110301 REC#120
• Status: Recruiting
• Phase: Phase 2
• Start date: July 1, 2023
• Est. completion date: May 2024

Study information

• Verified date: February 2024
• Source: Ain Shams University
• Contact: Omar El Rakabawy
• Phone: +201096195061
• Email: omar.mohamed20[@]pharma.asu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: May 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Dyslipidemias
• Hypertension

Intervention

Dietary Supplement:
• Puritans 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.

Locations

Country	Name	City	State
Egypt	Demerdash Hospital, Faculty of Medicine, Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(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
Primary	Blood Glucose Level	Fasting blood glucose (FBG) in mg/dl , Hemoglobin A1c (HbA1c) in percentage	Change from Baseline Blood Glucose Level at 14 weeks
Primary	Lipid Profile	Serum sample to determine ( Triglyceride level , LDL ,HDL ,Total cholesterol ) in mg/dl	Change from Baseline Lipid profile at 14 weeks
Primary	Blood Pressure	(SBP and DBP) in mmHg by using Sphygmomanometer	Change from Baseline Blood Pressure at 14 weeks
Primary	Heart Rate	Pulse in bpm	Change from Baseline Heart Rate at 14 weeks
Secondary	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
Secondary	Concentration of Malondialdehyde (MDA)	Serum sample to determine MDA (Oxidative stress marker)	Change from Baseline MDA concentration at 14 weeks
Secondary	International normalized ratio	Blood sample to determine INR level for those patients receiving anticoagulants	Change from Baseline INR level at 14 weeks
Secondary	Serum Ferritin	Serum Ferritin for those patients who are suspected to be anemic or are anemic.	Change from Baseline Ferritin concentration at 14 weeks