Kidney Transplant; Complications
Conditions
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.
Interventions
DRUGEmpagliflozin 25 MG
25 mg
DRUGInsulin
Insulin
Sponsors
Shahid Beheshti University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| serum level of superoxide dismutase | Change from baseline after 90 days of intervention | Serum level of antioxidant levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma levels of malondialdehyde | Change from baseline after 90 days of intervention | Serum level of antioxidant levels |
Countries
Iran
Outcome results
None listed