Clinical trial
Metformin IN Asthma for Overweight and Obese Individuals (MINA)
Recruiting now · Phase 2 · 1 countries · Registry ID NCT06273072
Recruiting nowPhase 2Interventional
What this study is about
This is a randomized clinical trial of metformin among overweight or obese adults with not well-controlled asthma despite maintenance inhaler therapy.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionAsthma, Asthma Chronic, Overweight and Obesity
Full registry 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)
Treatments and study arms
Metformin hydrochloride extended-release tablets
Drug
titrated to 2000 mg once daily
Visually identical placebo Metformin hydrochloride extended-release tablets
Drug
placebo
Primary outcomes
Number of completed telemedicine visitsBaseline to week 24
Number of participants completing at least 3 out of the 4 monitoring telemedicine visits
Adherence to study drugBaseline to week 24
Adherence will be measured by pill count
Retention rateBaseline to week 24
Investigators will collect data on the number of subjects screened, randomized, and complete the final in-person visit
Study locations
2 locations were listed when this page was built. The first 40 are shown.
Johns Hopkins University🇺🇸 Baltimore, Maryland, United States
Rachelle KoehlContact
Meredith C McCormack, M.D., M.H.S.Principal Investigator