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
Copyright © 2023 El-Khateeb, El-Berri, Mosalam, Nooh, Abdelsattar, Alghamdi, Alrubia and Abdallah..
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].
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:14 |
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| Enthalten in: |
Frontiers in pharmacology - 14(2023) vom: 13., Seite 1153653 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
El-Khateeb, Eman [VerfasserIn] |
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| Links: |
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| Themen: |
Diabetes |
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| Anmerkungen: |
Date Revised 30.04.2023 published: Electronic-eCollection ClinicalTrials.gov: NCT04075110 Citation Status PubMed-not-MEDLINE |
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| doi: |
10.3389/fphar.2023.1153653 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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NLM35617333X |
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| 100 | 1 | |a El-Khateeb, Eman |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Evaluating the safety and efficacy of the leukotriene receptor antagonist montelukast as adjuvant therapy in obese patients with type 2 diabetes mellitus |b A double-blind, randomized, placebo-controlled trial |
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| 500 | |a published: Electronic-eCollection | ||
| 500 | |a ClinicalTrials.gov: NCT04075110 | ||
| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 520 | |a Copyright © 2023 El-Khateeb, El-Berri, Mosalam, Nooh, Abdelsattar, Alghamdi, Alrubia and Abdallah. | ||
| 520 | |a 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] | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a T2DM | |
| 650 | 4 | |a diabetes | |
| 650 | 4 | |a leukotriene receptor antagonist | |
| 650 | 4 | |a metformin | |
| 650 | 4 | |a montelukast | |
| 650 | 4 | |a obesity | |
| 700 | 1 | |a El-Berri, Eman I |e verfasserin |4 aut | |
| 700 | 1 | |a Mosalam, Esraa M |e verfasserin |4 aut | |
| 700 | 1 | |a Nooh, Mohamed Z |e verfasserin |4 aut | |
| 700 | 1 | |a Abdelsattar, Shimaa |e verfasserin |4 aut | |
| 700 | 1 | |a Alghamdi, Amira M |e verfasserin |4 aut | |
| 700 | 1 | |a Alrubia, Sarah |e verfasserin |4 aut | |
| 700 | 1 | |a Abdallah, Mahmoud S |e verfasserin |4 aut | |
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