Effects of Empagliflozin in Reducing Oxidative Stress After Kidney Transplantation

Shahid Beheshti University of Medical Sciences

Status: Completed

Conditions: Kidney Transplant; Complications

Treatments: Drug: Insulin; Drug: Empagliflozin 25 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT04918407

SBMU98543

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Empagliflozin

Experimental group

Description:

Adding 25mg Empagliflozin on Insulin

Treatment:

Drug: Empagliflozin 25 MG

Drug: Insulin

Insulin alone

Active Comparator group

Description:

Just contriling the blood glucose with Insulin

Treatment:

Drug: Insulin