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

Early Phase 1

Completed

• Conditions: Obesity; Endocrine; Diabetes Type 2
• Interventions: Drug: Placebo; Drug: Montelukast 10mg

• Registration Number: NCT04075110
• Lead Sponsor: Sadat City University

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2019-08-28
• Study First Submitted QC: 2019-08-29
• Study First Posted: 2019-08-30
• Primary Completion: 2022-06-01
• Status Verified: 2023-04
• Study Completion: 2023-04-10
• Last Update Submitted: 2023-04-10
• Last Update Posted: 2023-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Placebo	50 patients will receive metformin up to 2000mg/daily (Control group)
Montelukast group	Montelukast 10mg	50 patients will receive a combination of metformin up to 2000 mg/daily and montelukast (10 mg /day).

Primary Outcome Measures

Name	Time	Method
Percent change in body weight	From baseline to 12 weeks	Body Weight
Visceral Adiposity Index	From baseline to 12 weeks	visceral fat
Change in HbA1c	From baseline to 12 weeks	HbA1c
BMI	From baseline to 12 weeks	body mass index

Secondary Outcome Measures

Name	Time	Method
Adiponectin	At baseline to 12 weeks	Serum level of adiponectin
TNF-α	At baseline to 12 weeks	Serum level of Tumor necrosis factor alpha (TNF-α)
IL-6	At baseline to 12 weeks	Serum level of interleukin-6 (IL-6)
leukotriene B4	At baseline to 12 weeks	Serum level of leukotriene B4 (LTB4)

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Shebin Elkom, Egypt