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Metformin IN Asthma for Overweight and Obese Individuals (MINA)
NCT06273072 · Johns Hopkins University
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
This is a randomized, placebo-controlled, parallel-arm pilot clinical trial. Adult participants who are overweight or obese and have not well-controlled asthma despite use of an inhaled corticosteroid will be randomized to metformin, an FDA-approved medication for the treatment of type 2 diabetes mellitus, or to placebo, to be taken daily for a total duration of six months. Recruitment will occur at two sites in the United States.
Randomized participants will have regular telemedicine visits to assess side effects and adherence. Additionally, participants will have a measurement of asthma outcomes at randomization and at 3 and 6 months after randomization.
The purpose of this study is to determine feasibility to inform a future multi-center clinical trial of metformin in this population.
Eligibility criteria
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)
Study design
Enrollment target: 100 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2024-12-09
Estimated completion: 2028-12-31
Last updated: 2026-01-16
Interventions
Drug: Metformin hydrochloride extended-release tabletsDrug: Visually identical placebo Metformin hydrochloride extended-release tablets
Primary outcomes
- • Number of completed telemedicine visits (Baseline to week 24)
- • Adherence to study drug (Baseline to week 24)
- • Retention rate (Baseline to week 24)
Sponsor
Johns Hopkins University · other
With: Baylor College of Medicine, National Heart, Lung, and Blood Institute (NHLBI), Temple University
Contacts & investigators
ContactRachelle Koehl, M.S. · contact · rkoehl1@jhmi.edu · 410-955-1530
ContactMeredith C McCormack, M.D., M.H.S. · contact · mmccor16@jhmi.edu · 410-550-6205
InvestigatorMeredith C McCormack, M.D., M.H.S. · principal_investigator, Johns Hopkins University
InvestigatorTianshi D Wu, M.D., M.H.S. · principal_investigator, Baylor College of Medicine
All locations (2)
Johns Hopkins UniversityRecruiting
Baltimore, Maryland, United States
Baylor College of MedicineRecruiting
Houston, Texas, United States