NCT06423729 - Effect of Nicorandil in Type 2 Diabetic Obese Patients | Crick | Crick

Effect of Nicorandil in Type 2 Diabetic Obese Patients

Phase 2CompletedNCT06423729

Tanta University46 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

46

Conditions

Diabetes Mellitus, Type 2

Interventions

Nicorandil 10 MGDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients newly diagnosed with diabetes . * 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.

Locations (1)

Faculty of Pharmacy, Tanta University

Tanta, Egypt

Outcomes

Primary Outcomes

Change in HbA1c level

Change in HbA1c (From baseline to 12 weeks)

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.

Change in body weight (From baseline to 12 weeks).

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)

Change in Body mass index (BMI) (From baseline to 12 weeks).

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).

Change in Visceral adiposity index (VAI) (From baseline to 12 weeks).

Time frame: The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.

Secondary Outcomes

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.

Time frame: The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.

Data from ClinicalTrials.gov

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