Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | 50 patients will receive metformin up to 2000mg/daily (Control group) |
|
| Montelukast group | Experimental | 50 patients will receive a combination of metformin up to 2000 mg/daily and montelukast (10 mg /day). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Montelukast 10mg | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine | Shebin Elkom | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37113754 | Derived | El-Khateeb E, El-Berri EI, Mosalam EM, Nooh MZ, Abdelsattar S, Alghamdi AM, Alrubia S, Abdallah MS. 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. Front Pharmacol. 2023 Apr 11;14:1153653. doi: 10.3389/fphar.2023.1153653. eCollection 2023. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | Placebo tablet once daily |
|
| 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 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C093875 | montelukast |
Not provided
Not provided
Not provided