Investigation the Safety and Efficacy of The Antileukotriene Agents, Montelukast, as Adjuvant Therapy in Obese Patients With Type 2 Diabetes Mellitus
1 other identifier
interventional
100
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Jul 2019
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2019
CompletedFirst Submitted
Initial submission to the registry
August 28, 2019
CompletedFirst Posted
Study publicly available on registry
August 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 10, 2023
CompletedApril 11, 2023
April 1, 2023
2.9 years
August 28, 2019
April 10, 2023
Conditions
Outcome Measures
Primary Outcomes (4)
Change in HbA1c
HbA1c
From baseline to 12 weeks
Percent change in body weight
Body Weight
From baseline to 12 weeks
BMI
body mass index
From baseline to 12 weeks
Visceral Adiposity Index
visceral fat
From baseline to 12 weeks
Secondary Outcomes (4)
Adiponectin
At baseline to 12 weeks
TNF-α
At baseline to 12 weeks
IL-6
At baseline to 12 weeks
leukotriene B4
At baseline to 12 weeks
Study Arms (2)
Control group
PLACEBO COMPARATOR50 patients will receive metformin up to 2000mg/daily (Control group)
Montelukast group
EXPERIMENTAL50 patients will receive a combination of metformin up to 2000 mg/daily and montelukast (10 mg /day).
Interventions
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.
Eligibility Criteria
You may qualify if:
- \- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine
Shebin Elkom, Egypt
Related Publications (1)
El-Khateeb E, El-Berri EI, Mosalam EM, Nooh MZ, Abdelsattar S, Alghamdi AM, Alrubia S, Abdallah MS. Evaluating the safety and efficacy of the leukotriene receptor antagonist montelukast as adjuvant therapy in obese patients with type 2 diabetes mellitus: A double-blind, randomized, placebo-controlled trial. Front Pharmacol. 2023 Apr 11;14:1153653. doi: 10.3389/fphar.2023.1153653. eCollection 2023.
PMID: 37113754DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Clinical Pharmacy, PhD.
Study Record Dates
First Submitted
August 28, 2019
First Posted
August 30, 2019
Study Start
July 1, 2019
Primary Completion
June 1, 2022
Study Completion
April 10, 2023
Last Updated
April 11, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF