Fenofibrate Versus Curcumin in Type 2 Diabetic Patients

February 16, 2022 updated by: Rehab Werida

Comparison of the Effect of Fenofibrate Versus Curcumin in Type 2 Diabetic Patients Treated With Glimepiride

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • El-Gharbia
      • Tanta, El-Gharbia, Egypt, 31527
        • Tanta University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fetuin-A (mg/L)
Time Frame: three months
human Fetuin A protein
three months
Sirtuin1 (SIRT1) (ng/ml)
Time Frame: three months
human Sirtuin1 a Protein - Recombinant human SIRT1 protein
three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Cholesterol (mg/dl)
Time Frame: Three Months
Total Cholesterol
Three Months
Triglyceride (mg/dl)
Time Frame: Three Months
Triglyceride
Three Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2020

Primary Completion (Actual)

November 30, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

August 22, 2020

First Submitted That Met QC Criteria

August 25, 2020

First Posted (Actual)

August 27, 2020

Study Record Updates

Last Update Posted (Actual)

March 4, 2022

Last Update Submitted That Met QC Criteria

February 16, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • fenofibrate vs curcumin

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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