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Curcumin's Effect on Diabetic Patients With Atherosclerotic Cardiovascular Risk

Primary Purpose

Diabetes Mellitus, Type 2, Dyslipidemias, Hypertension

Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Puritans Pride Turmeric curcumin® 500 mg
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus, ASCVD Risk, Curcumin, Inflammation, Oxidative stress, Diabetes complication

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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).

Sites / Locations

  • Demerdash Hospital, Faculty of Medicine, Ain Shams UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Group 1, Curcumin group

Group 2, Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

(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
Blood Glucose Level
Fasting blood glucose (FBG) in mg/dl , Hemoglobin A1c (HbA1c) in percentage
Lipid Profile
Serum sample to determine ( Triglyceride level , LDL ,HDL ,Total cholesterol ) in mg/dl
Blood Pressure
(SBP and DBP) in mmHg by using Sphygmomanometer
Heart Rate
Pulse in bpm

Secondary Outcome Measures

Concentration of Tumor necrosis factor alpha ( TNF-alpha)
Serum sample to determine TNF alpha (Inflammatory biomarker)
Concentration of Malondialdehyde (MDA)
Serum sample to determine MDA (Oxidative stress marker)
International normalized ratio
Blood sample to determine INR level for those patients receiving anticoagulants
Serum Ferritin
Serum Ferritin for those patients who are suspected to be anemic or are anemic.

Full Information

First Posted
January 31, 2023
Last Updated
July 18, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05753436
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Dyslipidemias, Hypertension
Keywords
Diabetes Mellitus, ASCVD Risk, Curcumin, Inflammation, Oxidative stress, Diabetes complication

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1, Curcumin group
Arm Type
Active Comparator
Arm Description
Group 1, Curcumin group (n=36): Patients will receive conventional treatment co-administrated with Turmeric Curcumin 500 mg thrice daily for 14 weeks.
Arm Title
Group 2, Control group
Arm Type
No Intervention
Arm Description
Group 2, Control group (n= 36): Patients will receive conventional therapy alone for 14 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Puritans Pride Turmeric curcumin® 500 mg
Other Intervention Name(s)
Curcumin
Intervention Description
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.
Primary Outcome Measure Information:
Title
(Atherosclerotic cardiovascular diseases risk score) Low-risk (<5%) Borderline risk (5% to 7.4%) Intermediate risk (7.5% to 19.9%) High risk (≥20%)
Description
10 year ASCVD risk calculation by using Pooled cohort equations
Time Frame
Change from Baseline ASCVD risk scoring at 14 weeks
Title
Blood Glucose Level
Description
Fasting blood glucose (FBG) in mg/dl , Hemoglobin A1c (HbA1c) in percentage
Time Frame
Change from Baseline Blood Glucose Level at 14 weeks
Title
Lipid Profile
Description
Serum sample to determine ( Triglyceride level , LDL ,HDL ,Total cholesterol ) in mg/dl
Time Frame
Change from Baseline Lipid profile at 14 weeks
Title
Blood Pressure
Description
(SBP and DBP) in mmHg by using Sphygmomanometer
Time Frame
Change from Baseline Blood Pressure at 14 weeks
Title
Heart Rate
Description
Pulse in bpm
Time Frame
Change from Baseline Heart Rate at 14 weeks
Secondary Outcome Measure Information:
Title
Concentration of Tumor necrosis factor alpha ( TNF-alpha)
Description
Serum sample to determine TNF alpha (Inflammatory biomarker)
Time Frame
Change from Baseline TNF-alpha concentration at 14 weeks
Title
Concentration of Malondialdehyde (MDA)
Description
Serum sample to determine MDA (Oxidative stress marker)
Time Frame
Change from Baseline MDA concentration at 14 weeks
Title
International normalized ratio
Description
Blood sample to determine INR level for those patients receiving anticoagulants
Time Frame
Change from Baseline INR level at 14 weeks
Title
Serum Ferritin
Description
Serum Ferritin for those patients who are suspected to be anemic or are anemic.
Time Frame
Change from Baseline Ferritin concentration at 14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Omar El Rakabawy
Phone
+201096195061
Email
omar.mohamed20@pharma.asu.edu.eg
Facility Information:
Facility Name
Demerdash Hospital, Faculty of Medicine, Ain Shams University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mona AbdelSalam, Ph.D
Email
monaabdelsalam@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

Curcumin's Effect on Diabetic Patients With Atherosclerotic Cardiovascular Risk

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