RecruitingPhase 2NCT06273072

Metformin IN Asthma for Overweight and Obese Individuals (MINA)


Sponsor

Johns Hopkins University

Enrollment

100 participants

Start Date

Dec 9, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a randomized clinical trial of metformin among overweight or obese adults with not well-controlled asthma despite maintenance inhaler therapy.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria11

  • 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)

Interventions

DRUGMetformin hydrochloride extended-release tablets

titrated to 2000 mg once daily

DRUGVisually identical placebo Metformin hydrochloride extended-release tablets

placebo


Locations(2)

Johns Hopkins University

Baltimore, Maryland, United States

Baylor College of Medicine

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06273072


Related Trials