Nephroprotective Effect of Nicorandil in Type 2 Diabetes Mellitus

May 21, 2024 updated by: Mohammed Atta Ali El-Hazzab, Tanta University

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 .

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

46

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
this group will include 23 patients who will receive metformin 2gm/day. The initial dose of metformin will be 1 g/day taken orally with the meal. After 7 days (week 1), the dose will be up titrated to daily dose of 2,000 mg/day. Treatment duration will be 12 weeks .
Active Comparator: Nicorandil group
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 .
Drug: Nicorandil 10 MG Oral Tablet
Nicorandil 10 MG oral tablet twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prevention of progression of kidney disease as measured by KDIGO.
Time Frame: 12 weeks
Patients wii undergo clinical assesment for progression of diabetic nephropathy as measured by KDIGO at baseline and after 12 weeks
12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2023

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

May 21, 2024

First Submitted That Met QC Criteria

May 21, 2024

First Posted (Actual)

May 28, 2024

Study Record Updates

Last Update Posted (Actual)

May 28, 2024

Last Update Submitted That Met QC Criteria

May 21, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nicorandil Nephroprotective

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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