Fenofibrate Versus Curcumin in Type 2 Diabetic Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Glimepiride Tablets
* Drug: glimepiride plus fenofibrate
* Drug: glimepiride plus curcumin


Participation Criteria
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Eligibility Criteria
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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: Other types of DM Hypersensitivity to the drug Abnormal liver function Patients with renal impairment (eGFR ≤ 60 ml/min) Addition of any antidiabetic medications or insulin during follows up. Pregnancy, lactation or child-bearing potential. 7. No insulin therapy and no use of antioxidants, multivitamin.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I<br>Glimepiride (4 mg) per Day | Drug: Glimepiride Tablets<br>* Glimepiride (4 mg) per Day<br>* Other names: Amaryl 4 mg;|
| Experimental: Group II<br>Glimepiride (4 mg) plus Fenofibrate (160 mg) per Day | Drug: glimepiride plus fenofibrate<br>* Glimepiride (4 mg) plus Fenofibrate (160 mg) per Day<br>* Other names: Amaryl 4 mg Plus Lipanthyl Supra (160 mg);|
| Experimental: Group III<br>Glimepiride (4 mg) plus Curcumin (1100 mg) With 5mg Black Pepper per Day | Drug: glimepiride plus curcumin<br>* Glimepiride (4 mg) plus Curcumin (1100 mg) With 5mg Black Pepper per Day<br>* Other names: Amaryl 4 mg Plus Curcumin (1100 mg) With 5mg Black Pepper;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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