Clinical trial NCT05753436: Curcumin's Effect on Diabetic Patients With Atherosclerotic Cardiovascular Risk
Official title: Evaluation of the Effect of Curcumin Administration on the Clinical Outcome of Diabetic Patients With Atherosclerotic Cardiovascular Risk
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Dyslipidemias
Hypertension
Keywords: Diabetes Mellitus
ASCVD Risk
Curcumin
Inflammation
Oxidative stress
Diabetes complication
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 72
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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).

Primary outcomes:
measure: (Atherosclerotic cardiovascular diseases risk score) Low-risk (<5%) Borderline risk (5% to 7.4%) Intermediate risk (7.5% to 19.9%) High risk (≥20%)
timeFrame: Change from Baseline ASCVD risk scoring at 14 weeks
measure: Blood Glucose Level
timeFrame: Change from Baseline Blood Glucose Level at 14 weeks
measure: Lipid Profile
timeFrame: Change from Baseline Lipid profile at 14 weeks
measure: Blood Pressure
timeFrame: Change from Baseline Blood Pressure at 14 weeks
measure: Heart Rate
timeFrame: Change from Baseline Heart Rate at 14 weeks
Secondary outcomes:
measure: Concentration of Tumor necrosis factor alpha ( TNF-alpha)
timeFrame: Change from Baseline TNF-alpha concentration at 14 weeks
measure: Concentration of Malondialdehyde (MDA)
timeFrame: Change from Baseline MDA concentration at 14 weeks
measure: International normalized ratio
timeFrame: Change from Baseline INR level at 14 weeks
measure: Serum Ferritin
timeFrame: Change from Baseline Ferritin concentration at 14 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Demerdash Hospital, Faculty of Medicine, Ain Shams University
Study officials:
References: