Nephroprotective Effect of Nicorandil in Type 2 Diabetes Mellitus

Phase 3RecruitingNCT06430125

Tanta University46 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Type2 Diabetes Mellitus

Interventions

Nicorandil 10 MG Oral TabletDRUG

Nicorandil 10 MG oral tablet twice daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

Tanta University

Tanta, EL Gharbia, Egypt

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 12 weeks

Secondary Outcomes

change in the serum concentrations of Kidney injury molecule 1(Kim-1).

Venous blood will be collected before treatment and after 12 week .

Time frame: 12 weeks

change in the serum concentrations of Interleukin 18 (IL-18).

Venous blood will be collected before treatment and after 12 week .

Time frame: 12 weeks

change in the serum concentrations of Nitric oxide (NO).

Venous blood will be collected before treatment and after 12 week .

Time frame: 12 weeks

Central Contacts

Mohammed A El-hazzab

CONTACT

201151998914 mohamed150556@pharm.tanta.edu.eg

Data from ClinicalTrials.gov

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