| Trial ID: | L3827 |
| Source ID: | NCT04075110
|
| Associated Drug: |
Montelukast 10mg
|
| Title: |
Investigation the Safety and Efficacy of The Antileukotriene Agents, Montelukast, as Adjuvant Therapy in Obese Patients With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Obesity; Endocrine; Diabetes Type 2
|
| Interventions: |
DRUG: Montelukast 10mg|DRUG: Placebo
|
| Outcome Measures: |
Primary: 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: Adiponectin, Serum level of adiponectin, At baseline to 12 weeks|TNF-α, Serum level of Tumor necrosis factor alpha (TNF-α), At baseline to 12 weeks|IL-6, Serum level of interleukin-6 (IL-6), At baseline to 12 weeks|leukotriene B4, Serum level of leukotriene B4 (LTB4), At baseline to 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: Sadat City University
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
EARLY_PHASE1
|
| Enrollment: |
100
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2019-07-01
|
| Completion Date: |
2023-04-10
|
| Results First Posted: |
|
| Last Update Posted: |
2023-04-11
|
| Locations: |
Faculty of Medicine, Shebin Elkom, Egypt
|
| URL: |
https://clinicaltrials.gov/show/NCT04075110
|
