Nephroprotective Effect of Nicorandil in Type 2 Diabetes Mellitus

Phase 3

Recruiting

• Conditions: Type2 Diabetes Mellitus
• Interventions: Drug: Nicorandil 10 MG Oral Tablet

• Registration Number: NCT06430125
• Lead Sponsor: Tanta University

Brief Summary

This study aims to evaluate the possible nephroprotective effect of nicorandil in patients with type 2 diabetes mellitus .

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-28
• Status Verified: 2024-05
• Study First Submitted: 2024-05-21
• Study First Submitted QC: 2024-05-21
• Last Update Submitted: 2024-05-21
• Study First Posted: 2024-05-28
• Last Update Posted: 2024-05-28
• Primary Completion: 2025-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 46

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nicorandil group	Nicorandil 10 MG Oral Tablet	this group will include 23 patients who will receive a combination of metformin 2g/day and nicorandil 10 mg twice daily. The initial dose of metformin will be 1 g/day taken orally with the meal. After 7 days (week 1), the dose will be uptitrated to daily dose of 2,000 mg/day. Treatment duration will be 12 weeks .

Primary Outcome Measures

Name	Time	Method
prevention of progression of kidney disease as measured by KDIGO.	12 weeks	Patients wii undergo clinical assesment for progression of diabetic nephropathy as measured by KDIGO at baseline and after 12 weeks

Secondary Outcome Measures

Name	Time	Method
change in the serum concentrations of Kidney injury molecule 1(Kim-1).	12 weeks	Venous blood will be collected before treatment and after 12 week .
change in the serum concentrations of Interleukin 18 (IL-18).	12 weeks	Venous blood will be collected before treatment and after 12 week .
change in the serum concentrations of Nitric oxide (NO).	12 weeks	Venous blood will be collected before treatment and after 12 week .

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, EL Gharbia, Egypt