Obesity; Endocrine; Diabetes Type 2
Conditions
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).
Interventions
DRUGMontelukast 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.
DRUGPlacebo
Placebo tablet once daily
Sponsors
Sadat City University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visceral Adiposity Index | From baseline to 12 weeks | visceral fat |
| Change in HbA1c | From baseline to 12 weeks | HbA1c |
| Percent change in body weight | From baseline to 12 weeks | Body Weight |
| BMI | From baseline to 12 weeks | body mass index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adiponectin | At baseline to 12 weeks | Serum level of adiponectin |
| TNF-α | At baseline to 12 weeks | Serum level of Tumor necrosis factor alpha (TNF-α) |
| IL-6 | At baseline to 12 weeks | Serum level of interleukin-6 (IL-6) |
| leukotriene B4 | At baseline to 12 weeks | Serum level of leukotriene B4 (LTB4) |
Countries
Egypt
Outcome results
None listed