Fenofibrate Versus Curcumin in Type 2 Diabetic Patients

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04528212
• Other study ID #: fenofibrate vs curcumin
• Status: Completed
• Phase: Phase 4
• Start date: November 1, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: February 2022
• Source: Damanhour University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 1, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• Glimepiride Tablets
Glimepiride (4 mg) per Day
• glimepiride plus fenofibrate
Glimepiride (4 mg) plus Fenofibrate (160 mg) per Day
• glimepiride plus curcumin
Glimepiride (4 mg) plus Curcumin (1100 mg) With 5mg Black Pepper per Day

Locations

Country	Name	City	State
Egypt	Tanta University Hospital	Tanta	El-Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Rehab Werida

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Noureldein MH, Abd El-Razek RS, El-Hefnawy MH, El-Mesallamy HO. Fenofibrate reduces inflammation in obese patients with or without type 2 diabetes mellitus via sirtuin 1/fetuin A axis. Diabetes Res Clin Pract. 2015 Sep;109(3):513-20. doi: 10.1016/j.diabre — View Citation

Panahi Y, Khalili N, Sahebi E, Namazi S, Reiner Ž, Majeed M, Sahebkar A. Curcuminoids modify lipid profile in type 2 diabetes mellitus: A randomized controlled trial. Complement Ther Med. 2017 Aug;33:1-5. doi: 10.1016/j.ctim.2017.05.006. Epub 2017 May 29. — View Citation

Poolsup N, Suksomboon N, Kurnianta PDM, Deawjaroen K. Effects of curcumin on glycemic control and lipid profile in prediabetes and type 2 diabetes mellitus: A systematic review and meta-analysis. PLoS One. 2019 Apr 23;14(4):e0215840. doi: 10.1371/journal. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fetuin-A (mg/L)	human Fetuin A protein	three months
Primary	Sirtuin1 (SIRT1) (ng/ml)	human Sirtuin1 a Protein - Recombinant human SIRT1 protein	three months
Secondary	Total Cholesterol (mg/dl)	Total Cholesterol	Three Months
Secondary	Triglyceride (mg/dl)	Triglyceride	Three Months