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
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Kidney Transplant; Complications

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