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

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ClinicalTrials.gov Identifier: NCT04075110
Recruitment Status : Recruiting
First Posted : August 30, 2019
Last Update Posted : September 2, 2019
Sponsor:
Information provided by (Responsible Party):
Mahmoud Samy Abdallah, 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).

Condition or disease Intervention/treatment Phase
Obesity; Endocrine; Diabetes Type 2 Drug: Montelukast 10mg Early Phase 1

Detailed Description:

Growing evidences have pointed to the role of 5-lipooxygenase / leukotriene pathway in the pathogenesis of diabesity. Cysteinyl leukotrienes (Cys-LT) are potent inflammatory lipid mediators derived from the 5-lipoxygenase pathway of arachidonic acid metabolism. They act on Cys-LT receptors that are primarily present in the spleen, blood leukocytes, and lung macrophages and are involved in mediation of inflammation. 5-lipoxygenase products exert potent proinflammatory actions, such as induction of nuclear factor (NF) - kB and secretion of proinflammatory and insulin resistant adipokines (i.e., monocyte chemotactic protein-1, tumor necrosis factor-a, macrophage inflammatory protein-1, and interleukin-6) that could potentially contribute to systemic insulin resistance. Furthermore, the physiological consequences of these changes in adipose tissue function were corroborated in vivo by the observation that inhibition of the 5-lipoxygenase pathway reduced proinflammatory cytokines and circulating free fatty acid concentrations, as well as alleviated insulin resistance and hepatic steatosis in experimental obesity.

Montelukast is a Cys-LT1-receptor antagonist that blocks the proinflammatory action of LTD4 . Montelukast is approved for the maintenance treatment of asthma and to relieve symptoms of seasonal allergies. It acts by inhibiting neutrophil infiltration, balancing oxidant-antioxidant status, and regulating the generation of inflammatory mediators.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Investigation the Safety and Efficacy of The Antileukotriene Agents, Montelukast, as Adjuvant Therapy in Obese Patients With Type 2 Diabetes Mellitus: A Randomized, Controlled Trial
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Montelukast

Arm Intervention/treatment
Placebo Comparator: Control group
50 patients will receive metformin 2000mg/daily (Control group)
Drug: Montelukast 10mg
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.

Experimental: Montelukast group
50 patients will receive a combination of metformin 2000 mg/daily and montelukast (10 mg /day).
Drug: Montelukast 10mg
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.




Primary Outcome Measures :
  1. Change in HbA1c [ Time Frame: From baseline to 12 weeks ]
    HbA1c

  2. Percent change in body weight [ Time Frame: From baseline to 12 weeks ]
    Body Weight

  3. BMI [ Time Frame: From baseline to 12 weeks ]
    body mass index

  4. Visceral Adiposity Index [ Time Frame: From baseline to 12 weeks ]
    visceral fat


Secondary Outcome Measures :
  1. Adiponectin [ Time Frame: At baseline to 12 weeks ]
    Serum level of adiponectin

  2. TNF-α [ Time Frame: At baseline to 12 weeks ]
    Serum level of Tumor necrosis factor alpha (TNF-α)

  3. IL-6 [ Time Frame: At baseline to 12 weeks ]
    Serum level of interleukin-6 (IL-6)

  4. leukotriene B4 [ Time Frame: At baseline to 12 weeks ]
    Serum level of leukotriene B4 (LTB4)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04075110


Contacts
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Contact: Mahmoud S Abdallah 00201063340887 Mahmoud.samy@fop.usc.edu.eg

Locations
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Egypt
Faculty of Medicine Recruiting
Shebin Elkom, Egypt
Contact: Mahmoud S Abdallah, PhD         
Sponsors and Collaborators
Sadat City University

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Responsible Party: Mahmoud Samy Abdallah, Lecturer of Clinical Pharmacy, PhD., Sadat City University
ClinicalTrials.gov Identifier: NCT04075110     History of Changes
Other Study ID Numbers: 0066/2019
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: September 2, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Montelukast
Leukotriene Antagonists
Anti-Asthmatic Agents
Respiratory System Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action