Investigating empagliflozin's effects on oxidative stress after kidney transplantation
Effects of Empagliflozin in Reducing Oxidative Stress of Diabetic Recipients After Kidney Transplantation
This study tests if adding empagliflozin to insulin therapy can reduce oxidative stress in people with type 2 diabetes after they have a kidney transplant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shahid Beheshti University of Medical Sciences Academic / other |
| Locations | 2 sites (Tehran and 1 other locations) |
| Trial ID | NCT04918407 on ClinicalTrials.gov |
What this trial studies
This study examines how empagliflozin, when added to insulin therapy, affects oxidative stress in patients with type 2 diabetes following kidney transplantation. It is a randomized, double-blinded trial involving 40 participants, divided into two groups: one receiving empagliflozin and insulin, and the other receiving insulin alone. The study measures various oxidative stress markers before and after a 90-day treatment period to assess the impact of empagliflozin on oxidative modifications. Results will be published in a peer-reviewed journal to contribute to the understanding of post-transplant care in diabetic patients.
Who should consider this trial
Good fit: Ideal candidates are patients with type 2 diabetes, stable graft function, and post-kidney transplant.
Not a fit: Patients who have undergone pancreas and kidney transplantation or have a history of recurrent urinary tract infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve post-transplant outcomes for diabetic patients by reducing oxidative stress.
How similar studies have performed: While the specific combination of empagliflozin and insulin in this context is novel, similar studies have shown promising results in managing oxidative stress in diabetic patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Tehran and 1 other locations
- Labbafinezhd Hospital — Tehran, Iran, Islamic Republic of (Recruiting)
- Sbmu — Tehran, Iran, Islamic Republic of (Recruiting)
Study contacts
- Principal investigator: Nooshin Dalili — Shahid Beheshti University of Medical Sciences
- Study coordinator: Nooshin Dalili
- Email: nooshindalili4@gmail.com
- Phone: 00989122404331
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.