Nephroprotective Effect of Nicorandil in Type 2 Diabetes Mellitus

Type2 Diabetes Mellitus Clinical Trial

Official title:

Clinical Study Evaluating the Nephroprotective Effect of Nicorandil in Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06430125
• Other study ID #: Nicorandil Nephroprotective
• Status: Recruiting
• Phase: Phase 3
• Start date: February 28, 2023
• Est. completion date: February 2025

Study information

• Verified date: May 2024
• Source: Tanta University
• Contact: Mohammed A El-hazzab
• Phone: 201151998914
• Email: mohamed150556[@]pharm.tanta.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes Mellitus

Intervention

Drug:
• Nicorandil 10 MG Oral Tablet
Nicorandil 10 MG oral tablet twice daily

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta	EL Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevention of progression of kidney disease as measured by KDIGO.	Patients wii undergo clinical assesment for progression of diabetic nephropathy as measured by KDIGO at baseline and after 12 weeks	12 weeks
Secondary	change in the serum concentrations of Kidney injury molecule 1(Kim-1).	Venous blood will be collected before treatment and after 12 week .	12 weeks
Secondary	change in the serum concentrations of Interleukin 18 (IL-18).	Venous blood will be collected before treatment and after 12 week .	12 weeks
Secondary	change in the serum concentrations of Nitric oxide (NO).	Venous blood will be collected before treatment and after 12 week .	12 weeks