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Fenofibrate Versus Curcumin in Type 2 Diabetic Patients

Sponsor
Rehab Werida (Other)
Overall Status
Completed
CT.gov ID
NCT04528212
Collaborator
(none)
60
Enrollment
1
Location
3
Arms
13
Actual Duration (Months)
4.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to evaluate the effect of fenofibrate versus curcumin on glycemic status, lipids profile, hs-CRP, sirtuin-1 and fetuin-A in type 2 diabetic patients who are taking glimepiride.

Condition or Disease Intervention/Treatment Phase
  • Drug: Glimepiride Tablets
  • Drug: glimepiride plus fenofibrate
  • Drug: glimepiride plus curcumin
 Phase 4

Detailed Description

Method & Proposal Steps

1- Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University. 2- All participants agreed to take part in this clinical study and provide informed consent. 3- (60) Patients with DM type 2 who's taking Glimepiride will be enrolled from Internal Medicine Department, Tanta University Hospital. 4- Serum samples will be collected for measuring the biomarkers. 5- All enrolled patients will be mentioned as two groups; Group I are patients who will be prescribed glimepiride plus fenofibrate. Group II are patients who will be prescribed glimepiride plus curcumin. 6- All patients will be followed up during 3 months' period. 7- At the end of 3 months on the new regimen, steps 4 will be repeated. 8- Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results. 9- Measuring outcome: The primary outcome is the change of serum levels of the measured markers after 3 months and lipid profile. 10- Results, conclusion, discussion and recommendations will be given.

Methodology Serum levels of fetuin-A, and Sirtuin1 (SIRT1) will be measured ELISA. Lipid profile. Fasting Blood glucose and 2 hrs postprandial Blood Glucose. Hb A1C will be measured. BMI of the patients will be measured before and after the study. High sensitivity C-reactive protein (hs-CRP) will be measured.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Masking Description:
Double Blind
Primary Purpose:
Treatment
Official Title:
Comparison of the Effect of Fenofibrate Versus Curcumin in Type 2 Diabetic Patients Treated With Glimepiride
Actual Study Start Date :
Nov 1, 2020
Actual Primary Completion Date :
Nov 30, 2021
Actual Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group I

Glimepiride (4 mg) per Day

Drug: Glimepiride Tablets
Glimepiride (4 mg) per Day
Other Names:
  • Amaryl 4 mg

    		•
    Experimental: Group II

    Glimepiride (4 mg) plus Fenofibrate (160 mg) per Day

    Drug: glimepiride plus fenofibrate
    Glimepiride (4 mg) plus Fenofibrate (160 mg) per Day
    Other Names:
  • Amaryl 4 mg Plus Lipanthyl Supra (160 mg)

    		•
    Experimental: Group III

    Glimepiride (4 mg) plus Curcumin (1100 mg) With 5mg Black Pepper per Day

    Drug: glimepiride plus curcumin
    Glimepiride (4 mg) plus Curcumin (1100 mg) With 5mg Black Pepper per Day
    Other Names:
  • Amaryl 4 mg Plus Curcumin (1100 mg) With 5mg Black Pepper

    		•

    Outcome Measures

    Primary Outcome Measures

    1. fetuin-A (mg/L) [three months]

      human Fetuin A protein

    2. Sirtuin1 (SIRT1) (ng/ml) [three months]

      human Sirtuin1 a Protein - Recombinant human SIRT1 protein

    Secondary Outcome Measures

    1. Total Cholesterol (mg/dl) [Three Months]

      Total Cholesterol

    2. Triglyceride (mg/dl) [Three Months]

      Triglyceride

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 60 Patients with type 2 DM diagnosed clinically.

    • The age ranged from 35 to 70 years.

    • There are no limits to the duration of DM and gender.

    • HbA1c ≥ 7

    Exclusion Criteria:

    1. Other types of DM

    2. Hypersensitivity to the drug

    3. Abnormal liver function

    4. Patients with renal impairment (eGFR ≤ 60 ml/min)

    5. Addition of any antidiabetic medications or insulin during follows up.

    6. Pregnancy, lactation or child-bearing potential. 7. No insulin therapy and no use of antioxidants, multivitamin.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tanta University Hospital Tanta El-Gharbia Egypt 31527

    Sponsors and Collaborators

    • Rehab Werida

    Investigators

    • Study Chair: Rehab H Werida, Ass.Prof., Damanhour University
    • Principal Investigator: Eman Nada, B. Pharm, Damanhour University
    • Study Director: Haidy Abass, Ass.Prof., Damanhour University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rehab Werida, Principal Investigator, Damanhour University
    ClinicalTrials.gov Identifier:
    NCT04528212
    Other Study ID Numbers:
    • fenofibrate vs curcumin
    First Posted:
    Aug 27, 2020
    Last Update Posted:
    Mar 4, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Diabetes Mellitus, Type 2
    Glimepiride
    Curcumin
    Fenofibrate

    Study Results

    No Results Posted as of Mar 4, 2022