Curcumin's Effect on Diabetic Patients With Atherosclerotic Cardiovascular Risk

Ain Shams University

Status and phase: Completed; Phase 2

Conditions: Hypertension; Dyslipidemias; Diabetes Mellitus, Type 2

Treatments: Dietary Supplement: Puritans Pride Turmeric curcumin® 500 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05753436

RHDIRB2020110301 REC#120

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Group 1, Curcumin group

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Puritans Pride Turmeric curcumin® 500 mg

Group 2, Control group

No Intervention group

Description:

Group 2, Control group (n= 36): Patients will receive conventional therapy alone for 14 weeks.