Effect of Nicorandil in Type 2 Diabetic Obese Patients

NCT06423729 | Recruiting Phase 2

• 1 other identifier: Nicorandil in DM
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 DM, Nicorandil, Obesity

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

• 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.

• 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 Outcomes (1)

• 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.

Study Arms (2)

Control Arm

NO INTERVENTION

23 patients who will receive 2nd generation sulfonylureas only, for three months.

Nicorandil Arm

EXPERIMENTAL

23 patients who will receive a combination of 2nd generation sulfonylureas and nicorandil 10 mg twice daily,for three months.

Drug: Nicorandil 10 MG

Interventions

Nicorandil 10 MG DRUG

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

Nicorandil Arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Pharmacy, Tanta University

Tanta, 31511, Egypt

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Interventions

Nicorandil

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitrates; Organic Chemicals; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Merna Mohamed Seddik Ali

CONTACT

+201026064628; merna198ali@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Merna Mohamed Seddik Ali , Master degree in Clinical Pharmacy, Tanta University

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 21, 2024
• Study Start: June 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: May 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)