Effects of Empagliflozin in Reducing Oxidative Stress After Kidney Transplantation

September 5, 2025 updated by: nooshin dalili, Shahid Beheshti University of Medical Sciences

Effects of Empagliflozin in Reducing Oxidative Stress of Diabetic Recipients After Kidney Transplantation

The purpose of this study is to investigate the effect of empagliflozin on oxidative stress in patients with type 2 diabetes after kidney transplantation. The association is examined by comparing the difference in oxidative modifications before and after 90 days treatment with 25 mg empagliflozin plus insulin compared to insulin treatment. The study is randomised and double-blinded. Each treatment group consists of 20 patients. Oxidative stress markers are measured by serum level of superoxide dismutase activity ,lipid peroxidation assay kit, glutathione assay, glutathione peroxidase activity , total antioxidant capacity assay oxidant status , carbonyl content assay and bca protein assay . . A student t-test will be performed to compare adding empagliflozin . The results will be published in a peer-review journal.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

With the purpose of studying the antioxidant activity of empagloflozin 25mg will add on insulin in 20 patients after kidney transplant and will compare with 20 diabetic recipient of kidney transplant on insulin therapy alone.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran
      • Tehran, Iran, 166663423
        • Labbafinezhd Hospital
      • Tehran, Iran, 1666664321
        • SBMU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed with type 2 diabetes
  • HbA1c: 6.5-9.0%
  • post kidney transplant
  • stable graft function

Exclusion Criteria:

  • pancreas and kidney transplant
  • history of recurrent urinary tract infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Empagliflozin
Adding 25mg Empagliflozin on Insulin
Drug: Insulin
Insulin
Drug: Empagliflozin 25 MG
25 mg
Active Comparator: Insulin alone
Just contriling the blood glucose with Insulin
Drug: Insulin
Insulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum level of superoxide dismutase
Time Frame: Change from baseline after 90 days of intervention
Serum level of antioxidant levels
Change from baseline after 90 days of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma levels of malondialdehyde
Time Frame: Change from baseline after 90 days of intervention
Serum level of antioxidant levels
Change from baseline after 90 days of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Beheshti University of Medical Sciences

Investigators

  • Principal Investigator: Nooshin Dalili, Shahid Beheshti University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

July 5, 2025

Study Completion (Actual)

August 5, 2025

Study Registration Dates

First Submitted

May 29, 2021

First Submitted That Met QC Criteria

June 7, 2021

First Posted (Actual)

June 8, 2021

Study Record Updates

Last Update Posted (Estimated)

September 8, 2025

Last Update Submitted That Met QC Criteria

September 5, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBMU98543

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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