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Metformin IN Asthma for Overweight and Obese Individuals (MINA)

Phase 2
Not yet recruiting
Conditions
Asthma
Asthma Chronic
Overweight 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

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)

Exclusion Criteria

Not provided

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Number of completed telemedicine visits;Adherence to study drug;Retention rate
Secondary Outcome Measures
NameTimeMethod
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
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