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

Obesity; Endocrine; Diabetes Type 2 Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04075110
• Other study ID #: 7-2021INTM1
• Status: Completed
• Phase: Early Phase 1
• Start date: July 1, 2019
• Est. completion date: April 10, 2023

Study information

• Verified date: April 2023
• Source: Sadat City University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 10, 2023
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity; Endocrine; Diabetes Type 2

Intervention

Drug:
• Montelukast 10mg
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
Placebo tablet once daily

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Shebin Elkom

Sponsors (1)

Lead Sponsor	Collaborator
Sadat City University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c	HbA1c	From baseline to 12 weeks
Primary	Percent change in body weight	Body Weight	From baseline to 12 weeks
Primary	BMI	body mass index	From baseline to 12 weeks
Primary	Visceral Adiposity Index	visceral fat	From baseline to 12 weeks
Secondary	Adiponectin	Serum level of adiponectin	At baseline to 12 weeks
Secondary	TNF-a	Serum level of Tumor necrosis factor alpha (TNF-a)	At baseline to 12 weeks
Secondary	IL-6	Serum level of interleukin-6 (IL-6)	At baseline to 12 weeks
Secondary	leukotriene B4	Serum level of leukotriene B4 (LTB4)	At baseline to 12 weeks