Effect of Nicorandil in Type 2 Diabetic Obese Patients

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06423729
• Other study ID #: Nicorandil in DM
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: June 1, 2024
• Est. completion date: January 2025

Study information

• Verified date: May 2024
• Source: Tanta University
• Contact: Merna Mohamed Seddik Ali
• Phone: +201026064628
• Email: merna198ali[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: January 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• Nicorandil 10 MG
Patients will receive oral Nicorandil 10 MG twice daily in addition to 2nd generation sulfonylureas , for 3 months.

Locations

Country	Name	City	State
Egypt	Faculty of Pharmacy, Tanta University	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c level	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.
Primary	Change in body weight.	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.
Primary	Change in Body mass index (BMI)	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.
Primary	Change in Visceral adiposity index (VAI).	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	Change in Adiponenctin, Interleukin-6 (IL-6) and Nitric oxide (NO) serum levels.	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.