Metformin IN Asthma for Overweight and Obese Individuals (MINA)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Metformin hydrochloride extended-release tablets, Visually identical placebo Metformin hydrochloride extended-release tablets.
- Who it may be relevant to
- Registry conditions: Asthma, Asthma Chronic, Overweight and Obesity. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This is a randomized clinical trial of metformin among overweight or obese adults with not well-controlled asthma despite maintenance inhaler therapy.
Detailed description
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.
Interventions
- Drug Metformin hydrochloride extended-release tablets
titrated to 2000 mg once daily - Drug Visually identical placebo Metformin hydrochloride extended-release tablets
placebo
Primary outcome measures
- Number of completed telemedicine visits [Time frame: Baseline to week 24]
- Adherence to study drug [Time frame: Baseline to week 24]
- Retention rate [Time frame: Baseline to week 24]
Secondary outcome measures (5)
- Asthma control as assessed by the Asthma Control Test (ACT) score [Time frame: Baseline to week 24]
- Change in Asthma exacerbations rate [Time frame: Baseline to week 24]
- Pre-bronchodilator lung function [Time frame: Baseline to week 24]
- Fractional exhaled nitric oxide (FeNO) [Time frame: Baseline to week 24]
- Airways hyperresponsiveness [Time frame: Baseline to week 24]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Johns Hopkins University — Baltimore
- Baylor College of Medicine — Houston
Identifiers
NCT: NCT06273072 · IRB00409080 · R34HL166438-01A1