NCT04528212

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4 diabetes-mellitus-type-2

Timeline
Completed

Started Nov 2020

Shorter than P25 for phase_4 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 27, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 4, 2022

Status Verified

February 1, 2022

Enrollment Period

1.1 years

First QC Date

August 22, 2020

Last Update Submit

February 16, 2022

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Total Cholesterol (mg/dl)

    Three Months

  • Triglyceride (mg/dl)

    Three Months

Study Arms (3)

Group I

EXPERIMENTAL

Glimepiride (4 mg) per Day

Drug: Glimepiride Tablets

Group II

EXPERIMENTAL

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

Drug: glimepiride plus fenofibrate

Group III

EXPERIMENTAL

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

Drug: glimepiride plus curcumin

Interventions

Glimepiride TabletsDRUG

Glimepiride (4 mg) per Day

Also known as: Amaryl 4 mg
Group I
glimepiride plus fenofibrateDRUG

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

Also known as: Amaryl 4 mg Plus Lipanthyl Supra (160 mg)
Group II
glimepiride plus curcuminDRUG

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

Also known as: Amaryl 4 mg Plus Curcumin (1100 mg) With 5mg Black Pepper
Group III

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University Hospital

Tanta, El-Gharbia, 31527, Egypt

Location

Related Publications (4)

  • 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.

    PMID: 28735818RESULT

  • 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.

    PMID: 31013312RESULT

  • 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.

    PMID: 26105582RESULT

  • Nada EM, El-Gharbawy NM, Abbas H, Werida RH. Effect of adding fenofibrate versus curcumin to glimepiride in patients with type 2 diabetes: a randomized controlled trial. BMC Pharmacol Toxicol. 2025 Jun 6;26(1):119. doi: 10.1186/s40360-025-00950-y.

    PMID: 40481568DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

glimepirideFenofibrateCurcumin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Fibric AcidsIsobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPhenyl EthersEthersBenzophenonesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenolsKetonesDiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicCatechols

Study Officials

  • Rehab H Werida, Ass.Prof.

    Damanhour University

    STUDY CHAIR

  • Eman Nada, B. Pharm

    Damanhour University

    PRINCIPAL INVESTIGATOR

  • Haidy Abass, Ass.Prof.

    Damanhour University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double Blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 22, 2020

First Posted

August 27, 2020

Study Start

November 1, 2020

Primary Completion

November 30, 2021

Study Completion

December 1, 2021

Last Updated

March 4, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)