Metformin IN Asthma for Overweight and Obese Individuals (MINA)
- Conditions
- AsthmaAsthma ChronicOverweight and Obesity
- Registration Number
- NCT06273072
- Lead Sponsor
- Johns Hopkins University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Physician-diagnosed asthma on maintenance therapy<br><br> - Not well-controlled asthma (ACT score <20, or at least one asthma exacerbation<br> requiring corticosteroids in the prior 12 months)<br><br> - Overweight or obesity: Body mass index =25kg/m2<br><br> - Adult: Age =18<br><br>Exclusion Criteria:<br><br> - Currently pregnant, expect to become pregnant in the next 6 months or are currently<br> breastfeeding<br><br> - Major cardiovascular disease: heart failure, heart attack or stroke within the last<br> 6 months<br><br> - Other chronic lung disease, inclusive of chronic obstructive pulmonary disease,<br> bronchiectasis, interstitial lung disease, pulmonary fibrosis<br><br> - Active smoking or former smoker with =20 pack-year smoking history<br><br> - Chronic kidney disease: estimated glomerular filtration rate =60 mL/min/1.73 m2<br><br> - Heavy alcohol use: in a typical week, 8 or more drinks for a woman or 15 or more<br> drinks for a man<br><br> - Liver disease: elevation in aspartate aminotransferase (AST) or alanine<br> aminotransferase (ALT) > 2x the upper limit of normal or prior diagnosis of liver<br> disease<br><br> - Anemia: hemoglobin < 13 g/dl in males and hemoglobin < 11 g/dl in females<br><br> - Taking Glucagon Like Peptide 1(GLP-1) medications for weight loss<br><br> - Diabetes (Hemoglobin A1C = 6.5% or taking metformin or other medications used to<br> treat diabetes)<br><br> - Participation in any other clinical trial (observational studies are permitted)
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of completed telemedicine visits;Adherence to study drug;Retention rate
- Secondary Outcome Measures
Name Time Method Asthma control as assessed by the Asthma Control Test (ACT) score;Change in Asthma exacerbations rate;Pre-bronchodilator lung function;Fractional exhaled nitric oxide (FeNO);Airways hyperresponsiveness