Effects of Empagliflozin in Reducing Oxidative Stress After Kidney Transplantation

Not Applicable

Recruiting

• Conditions: Kidney Transplant; Complications
• Interventions: Drug: Empagliflozin 25 MG; Drug: Insulin

• Registration Number: NCT04918407
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

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.

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 Timeline

• Study First Submitted: 2021-05-29
• Study First Submitted QC: 2021-06-07
• Study First Posted: 2021-06-08
• Study Start: 2022-01-01
• Status Verified: 2024-07
• Last Update Submitted: 2025-05-27
• Last Update Posted: 2025-05-28
• Primary Completion: 2026-08-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Empagliflozin	Empagliflozin 25 MG	Adding 25mg Empagliflozin on Insulin
Empagliflozin	Insulin	Adding 25mg Empagliflozin on Insulin
Insulin alone	Insulin	Just contriling the blood glucose with Insulin

Primary Outcome Measures

Name	Time	Method
serum level of superoxide dismutase	Change from baseline after 90 days of intervention	Serum level of antioxidant levels

Secondary Outcome Measures

Name	Time	Method
Plasma levels of malondialdehyde	Change from baseline after 90 days of intervention	Serum level of antioxidant levels

Trial Locations

Locations (2)

SBMU; 🇮🇷 Tehran, Iran, Islamic Republic of

Labbafinezhd Hospital; 🇮🇷 Tehran, Iran, Islamic Republic of