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Completed

NCT Number: NCT06423729

Effect of Nicorandil in Type 2 Diabetic Obese Patients

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Body Weight Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Pharmacy, Tanta University

Tanta, 31511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nicorandil 10 MG

Drug

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

Primary outcomes

  1. 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)

  2. 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).

  3. 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).

  4. 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).

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 21, 2024
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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