Curcumin's effects on diabetic patients at risk for heart disease
Evaluation of the Effect of Curcumin Administration on the Clinical Outcome of Diabetic Patients With Atherosclerotic Cardiovascular Risk
This study is testing if taking Curcumin can help people with Type 2 diabetes who are at risk for heart disease feel better by improving their blood pressure, cholesterol, and blood sugar levels while reducing inflammation.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT05753436 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and effectiveness of Curcumin supplementation alongside standard therapy in improving clinical outcomes, oxidative stress, and inflammation in patients with Type 2 diabetes who are at risk for atherosclerotic cardiovascular disease (ASCVD). It focuses on individuals aged 40 and older who have a 10-year ASCVD risk score of 5% or more and are diagnosed with hypertension and dyslipidemia. The intervention involves administering Puritans Pride Turmeric curcumin® 500 mg to assess its potential benefits in regulating blood pressure, lipid profiles, and blood glucose levels while reducing inflammation and oxidative stress.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40 and older with Type 2 diabetes, hypertension, and dyslipidemia who have a calculated ASCVD risk score of 5% or more.
Not a fit: Patients with existing cardiovascular diseases or those with certain liver conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel adjunct therapy for diabetic patients to reduce their risk of cardiovascular diseases.
How similar studies have performed: Other studies have suggested potential benefits of Curcumin in similar patient populations, but this specific approach is still being evaluated.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Cairo
- Demerdash Hospital, Faculty of Medicine, Ain Shams University — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Omar El Rakabawy
- Email: omar.mohamed20@pharma.asu.edu.eg
- Phone: +201096195061
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.