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Fenofibrate Versus Curcumin in Type 2 Diabetic Patients

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

Glimepiride Tablets

glimepiride plus fenofibrate

glimepiride plus curcumin

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Tanta University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Group I

Group II

Group III

Arm Description

Glimepiride (4 mg) per Day

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

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

Outcomes

Primary Outcome Measures

fetuin-A (mg/L)

human Fetuin A protein

Sirtuin1 (SIRT1) (ng/ml)

human Sirtuin1 a Protein - Recombinant human SIRT1 protein

Secondary Outcome Measures

Total Cholesterol (mg/dl)

Total Cholesterol

Triglyceride (mg/dl)

Triglyceride

Full Information

NCT ID

NCT04528212

First Posted

August 22, 2020

Last Updated

February 16, 2022

Sponsor

Rehab Werida

1. Study Identification

Unique Protocol Identification Number

NCT04528212

Brief Title

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

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

November 1, 2020 (Actual)

Primary Completion Date

November 30, 2021 (Actual)

Study Completion Date

December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Rehab Werida

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Masking Description

Double Blind

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group I

Arm Type

Experimental

Arm Description

Glimepiride (4 mg) per Day

Arm Title

Group II

Arm Type

Experimental

Arm Description

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

Arm Title

Group III

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Glimepiride Tablets

Other Intervention Name(s)

Amaryl 4 mg

Intervention Description

Glimepiride (4 mg) per Day

Intervention Type

Drug

Intervention Name(s)

glimepiride plus fenofibrate

Other Intervention Name(s)

Amaryl 4 mg Plus Lipanthyl Supra (160 mg)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

glimepiride plus curcumin

Other Intervention Name(s)

Amaryl 4 mg Plus Curcumin (1100 mg) With 5mg Black Pepper

Intervention Description

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

Primary Outcome Measure Information:

Title

fetuin-A (mg/L)

Description

human Fetuin A protein

Time Frame

three months

Title

Sirtuin1 (SIRT1) (ng/ml)

Description

human Sirtuin1 a Protein - Recombinant human SIRT1 protein

Time Frame

three months

Secondary Outcome Measure Information:

Title

Total Cholesterol (mg/dl)

Description

Total Cholesterol

Time Frame

Three Months

Title

Triglyceride (mg/dl)

Description

Triglyceride

Time Frame

Three Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rehab H Werida, Ass.Prof.

Organizational Affiliation

Damanhour University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Eman Nada, B. Pharm

Organizational Affiliation

Damanhour University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Haidy Abass, Ass.Prof.

Organizational Affiliation

Damanhour University

Official's Role

Study Director

Facility Information:

Facility Name

Tanta University Hospital

City

Tanta

State/Province

El-Gharbia

ZIP/Postal Code

31527

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28735818

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.

Results Reference

result

PubMed Identifier

31013312

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.

Results Reference

result

PubMed Identifier

26105582

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.

Results Reference

result

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Fenofibrate Versus Curcumin in Type 2 Diabetic Patients

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