NCT04528212

Fenofibrate Versus Curcumin in Type 2 Diabetic Patients

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Rehab Werida · Academic / Other
• Sex: All
• Age: 35 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Glimepiride Tablets	Glimepiride (4 mg) per Day
DRUG	glimepiride plus fenofibrate	Glimepiride (4 mg) plus Fenofibrate (160 mg) per Day
DRUG	glimepiride plus curcumin	Glimepiride (4 mg) plus Curcumin (1100 mg) With 5mg Black Pepper per Day

Timeline

• Start date: 2020-11-01
• Primary completion: 2021-11-30
• Completion: 2021-12-01
• First posted: 2020-08-27
• Last updated: 2022-03-04

Locations

1 site across 1 country: Egypt