Metformin IN Asthma for Overweight and Obese Individuals (MINA)
Recruiting · NCT06273072 · Interventional (participants receive a specific treatment) · Lead sponsor: Johns Hopkins University
View the official record on ClinicalTrials.gov →Interventions studied
Metformin hydrochloride extended-release tabletsVisually identical placebo Metformin hydrochloride extended-release tablets
What this trial is about
This is a randomized clinical trial of metformin among overweight or obese adults with not well-controlled asthma despite maintenance inhaler therapy.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Physician-diagnosed asthma on maintenance therapy
- Not well-controlled asthma (ACT score \<20, or at least one asthma exacerbation requiring corticosteroids in the prior 12 months)
- Overweight or obesity: Body mass index ≥25kg/m2
- Adult: Age ≥18
Exclusion criteria
- Currently pregnant, expect to become pregnant in the next 6 months or are currently breastfeeding
- Major cardiovascular disease: heart failure, heart attack or stroke within the last 6 months
- Other chronic lung disease, inclusive of chronic obstructive pulmonary disease, bronchiectasis, interstitial lung disease, pulmonary fibrosis
- Active smoking or former smoker with ≥20 pack-year smoking history
- Chronic kidney disease: estimated glomerular filtration rate ≤60 mL/min/1.73 m2
- Heavy alcohol use: in a typical week, 8 or more drinks for a woman or 15 or more drinks for a man
- Liver disease: elevation in aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2x the upper limit of normal or prior diagnosis of liver disease
- Anemia: hemoglobin \< 13 g/dl in males and hemoglobin \< 11 g/dl in females
- Taking Glucagon Like Peptide 1(GLP-1) medications for weight loss
- Diabetes (Hemoglobin A1C ≥ 6.5% or taking metformin or other medications used to treat diabetes)
- Participation in any other clinical trial (observational studies are permitted)
Where it is running
2 locations listed across 2 US states.
- Johns Hopkins University - Baltimore, Maryland, United States
- Baylor College of Medicine - Houston, Texas, United States