Fenofibrate Versus Curcumin in Type 2 Diabetic Patients

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Glimepiride Tablets; Drug: glimepiride plus fenofibrate; Drug: glimepiride plus curcumin

• Registration Number: NCT04528212
• Lead Sponsor: Rehab Werida

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.

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 Timeline

• Study First Submitted: 2020-08-22
• Study First Submitted QC: 2020-08-25
• Study First Posted: 2020-08-27
• Study Start: 2020-11-01
• Primary Completion: 2021-11-30
• Study Completion: 2021-12-01
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-16
• Last Update Posted: 2022-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I	Glimepiride Tablets	Glimepiride (4 mg) per Day
Group II	glimepiride plus fenofibrate	Glimepiride (4 mg) plus Fenofibrate (160 mg) per Day
Group III	glimepiride plus curcumin	Glimepiride (4 mg) plus Curcumin (1100 mg) With 5mg Black Pepper per Day

Primary Outcome Measures

Name	Time	Method
fetuin-A (mg/L)	three months	human Fetuin A protein
Sirtuin1 (SIRT1) (ng/ml)	three months	human Sirtuin1 a Protein - Recombinant human SIRT1 protein

Secondary Outcome Measures

Name	Time	Method
Total Cholesterol (mg/dl)	Three Months	Total Cholesterol
Triglyceride (mg/dl)	Three Months	Triglyceride

Trial Locations

Locations (1)

Tanta University Hospital; 🇪🇬 Tanta, El-Gharbia, Egypt