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.

Autor:	El-Khateeb E; Department of Clinical Pharmacy, Faculty of Pharmacy, Tanta University, Tanta, Al-Gharbia, Egypt.; Certara UK Limited (Simcyp Division), Sheffield, United Kingdom., El-Berri EI; Department of Clinical Pharmacy, Faculty of Pharmacy, Tanta University, Tanta, Al-Gharbia, Egypt., Mosalam EM; Department of Biochemistry, Faculty of Pharmacy, Menoufia University, Shebin ElKoum, Egypt., Nooh MZ; Department of Internal Medicine, Faculty of Medicine, Menoufia University, Shebin ElKoum, Egypt., Abdelsattar S; Department of Clinical Biochemistry and Molecular Diagnostics, National Liver Institute, Menoufia University, Shebin ElKoum, Egypt., Alghamdi AM; Department of Biochemistry, Faculty of Science, King Abdulaziz University, Jeddah, Saudi Arabia., Alrubia S; Pharmaceutical Chemistry Department, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia., Abdallah MS; Department of Clinical Pharmacy, Faculty of Pharmacy, University of Sadat City, Sadat City, Menoufia, Egypt.
Jazyk:	angličtina
Zdroj:	Frontiers in pharmacology [Front Pharmacol] 2023 Apr 11; Vol. 14, pp. 1153653. Date of Electronic Publication: 2023 Apr 11 (Print Publication: 2023).
DOI:	10.3389/fphar.2023.1153653
Abstrakt:	Background: Type 2 diabetes mellitus (T2DM) is common with obesity. Metformin is a first-line therapy for this condition. However, it has only a minor impact on weight loss in some patients. Aim: This study aimed to evaluate the effectiveness, tolerability, and safety of combining montelukast therapy with metformin in obese diabetic patients. Methods: One hundred obese diabetic adult patients were recruited and randomized into two equal groups. Group 1 received placebo plus metformin 2 g/d, and Group 2 received 2 g/d metformin plus 10 mg/d montelukast. Demographic, anthropometric measurements (e.g., body weight, body mass index [BMI], and visceral adiposity index), lipid profile, diabetes control measures (fasting blood glucose, glycated hemoglobin [HbA1c], and homeostatic model assessment for insulin resistance [HOMA-IR]), adiponectin, and inflammatory markers (e.g., TNF-α, IL-6, and leukotriene B4) were assessed and reported for each group at baseline and after 12 weeks of treatment. Results: Both interventions significantly reduced all the measured parameters, except for adiponectin and HDL-C, levels of which increased compared to baseline data ( p < 0.001). The montelukast group significantly improved in all parameters compared to the placebo group (ANCOVA test p < 0.001). The percentage changes in BMI, HbA1c, HOMA-IR, and inflammatory markers were 5%, 9%, 41%, and 5%-30%, respectively, in the placebo group compared to 8%, 16%, 58%, and 50%-70%, respectively, in the montelukast group. Conclusion: Montelukast adjuvant therapy was superior to metformin-only therapy in diabetes control and weight loss, most likely due to its increased insulin sensitivity and anti-inflammatory properties. The combination was tolerable and safe throughout the study duration. Clinical Trial Registration : [Clinicaltrial.gov], identifier [NCT04075110]. Competing Interests: Author EE-K was employed by Certara UK Limited (Simcyp Division). The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2023 El-Khateeb, El-Berri, Mosalam, Nooh, Abdelsattar, Alghamdi, Alrubia and Abdallah.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu