Effect of Nicorandil in Type 2 Diabetic Obese Patients

May 21, 2024 updated by: Merna Mohamed Seddik Ali, Tanta University

Clinical Study Evaluating the Effect of Nicorandil in Type 2 Diabetic Obese Patients Treated With Sulfonylurea

  1. Evaluating the effect of nicorandil on glycemic control of diabetic obese patients treated with sulfonylureas.
  2. Investigating the effect of nicorandil on body weight of diabetic obese patients treated with sulfonylureas.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

46

Phase

  • Phase 2
  • 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

  • Egypt
      • Tanta, Egypt, 31511
        • Recruiting
        • Faculty of Pharmacy, Tanta University
        • Contact:
        • Principal Investigator:
          • Merna Mohamed Seddik Ali

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:

  • Diabetes duration ranged from 1 to 10 years.
  • Body mass index (BMI) >30 Kg/m2.
  • The selected patients are treated with sulfonylureas alone.
  • The age of selected patient ranged from 18 and 60 years.

Exclusion Criteria:

  • Pregnant and lactating females.
  • Patients with hypersensitivity to nicorandil.
  • Uncontrolled hypertension and its antihypertensive medications
  • Severe renal or hepatic disease.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Arm
23 patients who will receive 2nd generation sulfonylureas only, for three months.
Experimental: Nicorandil Arm
23 patients who will receive a combination of 2nd generation sulfonylureas and nicorandil 10 mg twice daily,for three months.
Drug: Nicorandil 10 MG
Patients will receive oral Nicorandil 10 MG twice daily in addition to 2nd generation sulfonylureas , for 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c level
Time Frame: The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.
Change in HbA1c (From baseline to 12 weeks)
The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.
Change in body weight.
Time Frame: The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.
Change in body weight (From baseline to 12 weeks).
The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.
Change in Body mass index (BMI)
Time Frame: The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.
Change in Body mass index (BMI) (From baseline to 12 weeks).
The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.
Change in Visceral adiposity index (VAI).
Time Frame: The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.
Change in Visceral adiposity index (VAI) (From baseline to 12 weeks).
The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Adiponenctin, Interleukin-6 (IL-6) and Nitric oxide (NO) serum levels.
Time Frame: The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.
Assessment of Adiponenctin, Interleukin-6 (IL-6) and Nitric oxide levels by ELISA Kits according to manufacturer's instructions.
The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.

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 (Estimated)

June 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

May 16, 2024

First Submitted That Met QC Criteria

May 16, 2024

First Posted (Actual)

May 21, 2024

Study Record Updates

Last Update Posted (Actual)

May 23, 2024

Last Update Submitted That Met QC Criteria

May 21, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nicorandil in DM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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