RECRUITING

Metformin IN Asthma for Overweight and Obese Individuals (MINA)

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Conditions

AsthmaAsthma ChronicOverweight and Obesity

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Metformin IN Asthma for Overweight and Obese Individuals (MINA)

Quick Facts

Study Start:2024-12-09
Study Completion:2028-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06273072

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Physician-diagnosed asthma on maintenance therapy
  2. * Not well-controlled asthma (ACT score \<20, or at least one asthma exacerbation requiring corticosteroids in the prior 12 months)
  3. * Overweight or obesity: Body mass index ≥25kg/m2
  4. * Adult: Age ≥18
  1. * Currently pregnant, expect to become pregnant in the next 6 months or are currently breastfeeding
  2. * Major cardiovascular disease: heart failure, heart attack or stroke within the last 6 months
  3. * Other chronic lung disease, inclusive of chronic obstructive pulmonary disease, bronchiectasis, interstitial lung disease, pulmonary fibrosis
  4. * Active smoking or former smoker with ≥20 pack-year smoking history
  5. * Chronic kidney disease: estimated glomerular filtration rate ≤60 mL/min/1.73 m2
  6. * Heavy alcohol use: in a typical week, 8 or more drinks for a woman or 15 or more drinks for a man
  7. * Liver disease: elevation in aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2x the upper limit of normal or prior diagnosis of liver disease
  8. * Anemia: hemoglobin \< 13 g/dl in males and hemoglobin \< 11 g/dl in females
  9. * Taking Glucagon Like Peptide 1(GLP-1) medications for weight loss
  10. * Diabetes (Hemoglobin A1C ≥ 6.5% or taking metformin or other medications used to treat diabetes)
  11. * Participation in any other clinical trial (observational studies are permitted)

Contacts and Locations

Study Contact

Rachelle Koehl, M.S.
CONTACT
410-955-1530
rkoehl1@jhmi.edu
Meredith C McCormack, M.D., M.H.S.
CONTACT
410-550-6205
mmccor16@jhmi.edu

Principal Investigator

Meredith C McCormack, M.D., M.H.S.
PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Tianshi D Wu, M.D., M.H.S.
PRINCIPAL_INVESTIGATOR
Baylor College of Medicine

Study Locations (Sites)

Johns Hopkins University
Baltimore, Maryland, 21224
United States
Baylor College of Medicine
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Meredith C McCormack, M.D., M.H.S., PRINCIPAL_INVESTIGATOR, Johns Hopkins University
  • Tianshi D Wu, M.D., M.H.S., PRINCIPAL_INVESTIGATOR, Baylor College of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-09
Study Completion Date2028-12-31

Study Record Updates

Study Start Date2024-12-09
Study Completion Date2028-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Asthma
  • Asthma Chronic
  • Overweight and Obesity