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OpenTrials
Completed

NCT Number: NCT04075110

Investigation the Safety and Efficacy of The Antileukotriene Agents, Montelukast, as Adjuvant Therapy in Obese Patients With Type 2 Diabetes Mellitus

The aim of the current study is to evaluate the safety and efficacy of Montelukast in treatment of obese patients with type 2 diabetes (T2DM).

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Key information

Conditions

Obesity; Endocrine; Diabetes Type 2 Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 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

Early Phase 1

Primary location

Faculty of Medicine

Shebin Elkom, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • type 2 diabetic patients who had body mass index (BMI) ≥ 30 kg/m2 , were treated with metformin alone and had ages ranging from 18 to 60 years.

Exclusion criteria

  • patients who had any other inflammatory disease
  • patients with cardiovascular,
  • patients with asthma
  • patients with severe hepatic
  • patients with renal disease,
  • patients with epilepsy
  • pregnant or lactating females.

Treatment and study plan

Montelukast 10mg

Drug

Montelukast is an orally dosed drug (available as a chewable tablet) which is FDA-approved for the treatment of chronic asthma and prophylaxis and the prevention of exercise-induced bronchoconstriction. It is also approved for the relief of symptoms of both seasonal and perennial allergic rhinitis.

Placebo

Drug

Placebo tablet once daily

Primary outcomes

  1. Change in HbA1c

    Time frame: From baseline to 12 weeks

    HbA1c

  2. Percent change in body weight

    Time frame: From baseline to 12 weeks

    Body Weight

  3. BMI

    Time frame: From baseline to 12 weeks

    body mass index

  4. Visceral Adiposity Index

    Time frame: From baseline to 12 weeks

    visceral fat

Secondary outcomes

  1. Adiponectin

    Time frame: At baseline to 12 weeks

    Serum level of adiponectin

  2. TNF-α

    Time frame: At baseline to 12 weeks

    Serum level of Tumor necrosis factor alpha (TNF-α)

  3. IL-6

    Time frame: At baseline to 12 weeks

    Serum level of interleukin-6 (IL-6)

  4. leukotriene B4

    Time frame: At baseline to 12 weeks

    Serum level of leukotriene B4 (LTB4)

Sponsors and collaborators

Lead sponsor

Sadat City University

Other

Registry information

Official study title

Investigation the Safety and Efficacy of The Antileukotriene Agents, Montelukast, as Adjuvant Therapy in Obese Patients With Type 2 Diabetes Mellitus: A Randomized, Controlled Trial

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Aug 30, 2019
Registry last updated
Apr 11, 2023

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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