Curcumin's Effect on Diabetic Patients With Atherosclerotic Cardiovascular Risk

NCT05753436 | Completed Phase 2 FDA Drug

• 1 other identifier: RHDIRB2020110301 REC#120
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Dyslipidemias; Hypertension

Keywords

Diabetes Mellitus; ASCVD Risk; Curcumin; Inflammation; Oxidative stress; Diabetes complication

Outcome Measures

Primary Outcomes (5)

• (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

• Blood Glucose Level

  Fasting blood glucose (FBG) in mg/dl , Hemoglobin A1c (HbA1c) in percentage

  Change from Baseline Blood Glucose Level at 14 weeks

• Lipid Profile

  Serum sample to determine ( Triglyceride level , LDL ,HDL ,Total cholesterol ) in mg/dl

  Change from Baseline Lipid profile at 14 weeks

• Blood Pressure

  (SBP and DBP) in mmHg by using Sphygmomanometer

  Change from Baseline Blood Pressure at 14 weeks

• Heart Rate

  Pulse in bpm

  Change from Baseline Heart Rate at 14 weeks

Secondary Outcomes (4)

• Concentration of Tumor necrosis factor alpha ( TNF-alpha)

  Change from Baseline TNF-alpha concentration at 14 weeks

• Concentration of Malondialdehyde (MDA)

  Change from Baseline MDA concentration at 14 weeks

• International normalized ratio

  Change from Baseline INR level at 14 weeks

• Serum Ferritin

  Change from Baseline Ferritin concentration at 14 weeks

Study Arms (2)

Group 1, Curcumin group

ACTIVE COMPARATOR

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

Dietary Supplement: Puritans Pride Turmeric curcumin® 500 mg

Group 2, Control group

NO INTERVENTION

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

Interventions

Puritans Pride Turmeric curcumin® 500 mg DIETARY_SUPPLEMENT

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.

Also known as: Curcumin

Group 1, Curcumin group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult Male or female patients aged 40 years or older
• A calculated 10 year ASCVD risk score of 5 % or more
• Patient previously or newly diagnosed with hypertension
• Patient previously or newly diagnosed with dyslipidaemia
• Patients diagnosed as Type 2 diabetes mellitus taking insulin or oral hypoglycemic agent with controlled HbA1c \< 10%
• Willingness and ability to give informed consent.

You may not qualify if:

• Congenital or acquired bleeding disorders.
• Cholelithiasis, gall bladder or biliary tract disease or other active liver diseases.
• Pregnant or breastfeeding women.
• Oral hypoglycemic drugs that affect cardiovascular diseases risk.
• Patients with clinical ASCVD (myocardial infarction, stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack, or peripheral arterial disease).

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Demerdash Hospital, Faculty of Medicine, Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Dyslipidemias; Hypertension; Diabetes Mellitus; Inflammation; Diabetes Complications

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: March 3, 2023
• Study Start: July 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: March 1, 2024
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)