Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Fenofibrate Versus Curcumin in Type 2 Diabetic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04528212
Recruitment Status : Completed
First Posted : August 27, 2020
Last Update Posted : March 4, 2022
Sponsor:
Information provided by (Responsible Party):
Rehab Werida, Damanhour University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Diabetes Mellitus, Type 2 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : November 1, 2020
Actual Primary Completion Date : November 30, 2021
Actual Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Group I
Glimepiride (4 mg) per Day
 Drug: Glimepiride Tablets
Glimepiride (4 mg) per Day
Other Name: 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 Name: 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 Name: Amaryl 4 mg Plus Curcumin (1100 mg) With 5mg Black Pepper


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. fetuin-A (mg/L) [ Time Frame: three months ]
    human Fetuin A protein

  2. Sirtuin1 (SIRT1) (ng/ml) [ Time Frame: three months ]
    human Sirtuin1 a Protein - Recombinant human SIRT1 protein


Secondary Outcome Measures :
  1. Total Cholesterol (mg/dl) [ Time Frame: Three Months ]
    Total Cholesterol

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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04528212


Locations
Layout table for location information
Egypt
Tanta University Hospital
Tanta, El-Gharbia, Egypt, 31527
Sponsors and Collaborators
Rehab Werida
Investigators
Layout table for investigator information
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
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
Responsible Party: Rehab Werida, Principal Investigator, Damanhour University
ClinicalTrials.gov Identifier: NCT04528212    
Other Study ID Numbers: fenofibrate vs curcumin
First Posted: August 27, 2020    Key Record Dates
Last Update Posted: March 4, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Curcumin
Fenofibrate
Anti-Arrhythmia Agents
Hypoglycemic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
 Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents