Effects of Empagliflozin in Reducing Oxidative Stress After Kidney Transplantation

NCT04918407 | Completed

• 1 other identifier: SBMU98543
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Kidney Transplant; Complications

Outcome Measures

Primary Outcomes (1)

• serum level of superoxide dismutase

  Serum level of antioxidant levels

  Change from baseline after 90 days of intervention

Secondary Outcomes (1)

• Plasma levels of malondialdehyde

  Change from baseline after 90 days of intervention

Study Arms (2)

Empagliflozin

EXPERIMENTAL

Adding 25mg Empagliflozin on Insulin

Drug: Empagliflozin 25 MG; Drug: Insulin

Insulin alone

ACTIVE COMPARATOR

Just contriling the blood glucose with Insulin

Drug: Insulin

Interventions

Empagliflozin 25 MG DRUG

25 mg

Empagliflozin

Insulin DRUG

Insulin

Empagliflozin; Insulin alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (2)

Labbafinezhd Hospital

Tehran, 166663423, Iran

Location

SBMU

Tehran, 1666664321, Iran

Location

MeSH Terms

Interventions

empagliflozin; Insulin

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Nooshin Dalili

  Shahid Beheshti University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of SBMU

Study Record Dates

• First Submitted: May 29, 2021
• First Posted: June 8, 2021
• Study Start: January 1, 2022
• Primary Completion: July 5, 2025
• Study Completion: August 5, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IR (2)