Effect of Nicorandil in Type 2 Diabetic Obese Patients

Phase 2

Recruiting

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Nicorandil 10 MG

• Registration Number: NCT06423729
• Lead Sponsor: Tanta University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-16
• Study First Submitted QC: 2024-05-16
• Study First Posted: 2024-05-21
• Last Update Submitted: 2024-05-21
• Last Update Posted: 2024-05-23
• Study Start: 2024-06-01
• Primary Completion: 2024-12
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nicorandil Arm	Nicorandil 10 MG	23 patients who will receive a combination of 2nd generation sulfonylureas and nicorandil 10 mg twice daily,for three months.

Primary Outcome Measures

Name	Time	Method
Change in HbA1c level	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)
Change in body weight.	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).
Change in Body mass index (BMI)	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).
Change in Visceral adiposity index (VAI).	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).

Secondary Outcome Measures

Name	Time	Method
Change in Adiponenctin, Interleukin-6 (IL-6) and Nitric oxide (NO) serum levels.	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.

Trial Locations

Locations (1)

Faculty of Pharmacy, Tanta University; 🇪🇬 Tanta, Egypt