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

Sadat City University

Status and phase: Completed; Early Phase 1

Conditions: Obesity; Endocrine; Diabetes Type 2

Treatments: Drug: Placebo; Drug: Montelukast 10mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04075110

7-2021INTM1

Details and patient eligibility

About

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).

Enrollment: 100 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

50 patients will receive metformin up to 2000mg/daily (Control group)

Treatment:

Drug: Placebo

Montelukast group

Experimental group

Description:

50 patients will receive a combination of metformin up to 2000 mg/daily and montelukast (10 mg /day).

Treatment:

Drug: Montelukast 10mg