Clinical trial NCT04528212: Fenofibrate Versus Curcumin in Type 2 Diabetic Patients
Official title: Comparison of the Effect of Fenofibrate Versus Curcumin in Type 2 Diabetic Patients Treated With Glimepiride
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Damanhour University
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: fetuin-A (mg/L)
timeFrame: three months
measure: Sirtuin1 (SIRT1) (ng/ml)
timeFrame: three months
Secondary outcomes:
measure: Total Cholesterol (mg/dl)
timeFrame: Three Months
measure: Triglyceride (mg/dl)
timeFrame: Three Months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospital
state: El-Gharbia
Study officials:
affiliation: Damanhour University
name: Rehab H Werida, Ass.Prof.
role: STUDY_CHAIR
affiliation: Damanhour University
name: Eman Nada, B. Pharm
role: PRINCIPAL_INVESTIGATOR
affiliation: Damanhour University
name: Haidy Abass, Ass.Prof.
role: STUDY_DIRECTOR
References:
citation: Panahi Y, Khalili N, Sahebi E, Namazi S, Reiner Z, 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.
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.pone.0215840. eCollection 2019.
citation: 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.diabres.2015.05.043. Epub 2015 Jun 11.