Fenofibrate Versus Curcumin in Type 2 Diabetic Patients

Rehab Werida60 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetes Mellitus, Type 2

Interventions

Glimepiride TabletsDRUG

Glimepiride (4 mg) per Day

glimepiride plus fenofibrateDRUG

Glimepiride (4 mg) plus Fenofibrate (160 mg) per Day

glimepiride plus curcuminDRUG

Glimepiride (4 mg) plus Curcumin (1100 mg) With 5mg Black Pepper per Day

Eligibility

Sex: ALLMin age: 35 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Tanta University Hospital

Tanta, El-Gharbia, Egypt

Outcomes

Primary Outcomes

fetuin-A (mg/L)

human Fetuin A protein

Time frame: three months

Sirtuin1 (SIRT1) (ng/ml)

human Sirtuin1 a Protein - Recombinant human SIRT1 protein

Time frame: three months

Secondary Outcomes

Total Cholesterol (mg/dl)

Total Cholesterol

Time frame: Three Months

Triglyceride (mg/dl)

Triglyceride

Time frame: Three Months

Data from ClinicalTrials.gov

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