| Trial ID: | L2112 |
| Source ID: | NCT06731231
|
| Associated Drug: |
Sglt2 Inhibitor
|
| Title: |
SGLT2i in Diabetic Patients with Renal Transplantation
|
| Acronym: |
|
| Status: |
ACTIVE_NOT_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Post-transplant Diabetes Mellitus
|
| Interventions: |
DRUG: SGLT2 inhibitor
|
| Outcome Measures: |
Primary: Glycemic control by SGLT2i in post renal transplantation diabetic patients, The primary outcome was the control of fasting blood sugar with no episodes of hypoglycemic attacks with reduction of HbA1c, 6 months|Assessing SGLT2i-related side effects in the intervention arm in comparison to the control arm, serious adverse events and adverse events of interest that may lead to premature discontinuation,interruption, or dose reduction of the study drug. Adverse effects of interest include volume depletion, UTI and genital infections, acute rejection, major hypoglycemia,, potential diabetic ketoacidosis, adverse effects leading to amputations, or events increasing the risk of lower-limb amputations., 6 months |
|
| Sponsor/Collaborators: |
Sponsor: Ain Shams University
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
72
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
|
| Start Date: |
2024-03-15
|
| Completion Date: |
2025-01
|
| Results First Posted: |
|
| Last Update Posted: |
2024-12-12
|
| Locations: |
Ain Shams university hospital, Cairo, Egypt
|
| URL: |
https://clinicaltrials.gov/show/NCT06731231
|
