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NCT04918407 Clinical Trial

Effects of Empagliflozin in Reducing Oxidative Stress After Kidney Transplantation

Kidney Transplant; Complications Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04918407
Other study ID # SBMU98543
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2022
Est. completion date October 1, 2025

Study information
Verified date July 2023
Source Shahid Beheshti University of Medical Sciences
Contact Nooshin Dalili
Phone 00989122404331
Email nooshindalili4@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date October 1, 2025
Est. primary completion date August 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Empagliflozin 25 MG
25 mg
• Insulin
Insulin

Locations
Country Name City State
Iran, Islamic Republic of Labbafinezhd Hospital Tehran
Iran, Islamic Republic of SBMU Tehran

Sponsors (1)
Lead Sponsor Collaborator
Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary serum level of superoxide dismutase Serum level of antioxidant levels Change from baseline after 90 days of intervention
Secondary Plasma levels of malondialdehyde Serum level of antioxidant levels Change from baseline after 90 days of intervention
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