Type2 Diabetes Mellitus Clinical Trial
Official title:
Clinical Study Evaluating the Nephroprotective Effect of Nicorandil in Patients With Type 2 Diabetes Mellitus
This study aims to evaluate the possible nephroprotective effect of nicorandil in patients with type 2 diabetes mellitus .
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Tanta University | Tanta | EL Gharbia |
Lead Sponsor | Collaborator |
---|---|
Tanta University |
Egypt,
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 |
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