Evaluating the kidney-protective effects of nicorandil in type 2 diabetes patients
Clinical Study Evaluating the Nephroprotective Effect of Nicorandil in Patients With Type 2 Diabetes Mellitus
This study is testing if nicorandil can help protect the kidneys in people who have just been diagnosed with type 2 diabetes and have controlled blood pressure and blood sugar levels.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, EL Gharbia) |
| Trial ID | NCT06430125 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the nephroprotective effects of nicorandil in patients newly diagnosed with type 2 diabetes mellitus who have controlled hypertension and good glycemic control. The study will involve administering nicorandil in a controlled setting to assess its impact on kidney function in individuals with stage 1 and stage 2 chronic kidney disease. Participants will be closely monitored for changes in kidney health and overall metabolic control throughout the trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 60 with newly diagnosed type 2 diabetes and stage 1 or 2 chronic kidney disease.
Not a fit: Patients with uncontrolled hypertension, other causes of chronic kidney disease, or those taking nephrotoxic medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic option to protect kidney function in patients with type 2 diabetes.
How similar studies have performed: While the nephroprotective effects of nicorandil have been explored in other contexts, this specific application in type 2 diabetes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients newly diagnosed with T2DM with diet control and good glycemic index ( Hb A1C\< 7 ) * Age range between 18 and 60 years old. * Both sexes. * Stage 1and Stage 2 CKD according to KDIGO . * Controlled HTN . Exclusion Criteria: * Pregnant and lactating females. * Patients with hypersensitivity to nicorandil. * Other Causes of CKD or Nephropathy eg : Uncontrolled HTN , Renal Malignancy , collagen disease as Amyloidosis and some autoimmune disease as ( SLE and Rh.fever ) . * Uncontrolled HTN and its antihypertensive medications ( ACEI , ARB ) and other antihypertensive medications . * Patients receiving nephrotoxic drugs as aminoglycosides, non-steroidal anti inflammatory drugs and contrast media.
Where this trial is running
Tanta, EL Gharbia
- Tanta University — Tanta, EL Gharbia, Egypt (Recruiting)
Study contacts
- Study coordinator: Mohammed A El-hazzab
- Email: mohamed150556@pharm.tanta.edu.eg
- Phone: 201151998914
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.