Metformin's effects on lung function in patients with cystic fibrosis-related diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of metformin in improving airway ion channel function in patients diagnosed with cystic fibrosis-related diabetes (CFRD). Up to 30 eligible participants will be randomized to receive either a low or normal dose of metformin, with a crossover design allowing each participant to experience both dosing regimens over a 14-week period. A placebo will be used to ensure that participants are unaware of which treatment they are receiving. Additionally, to mitigate the risk of vitamin B12 deficiency associated with metformin, participants will receive a daily supplement of cyanocobalamin throughout the trial.

Why it matters

Who can join: the full rules

Inclusion criteria:

1. Age \>18 years with a prior diagnosis of CF.
2. Use of ivacaftor or elexacaftor/tezacaftor/ivacaftor or vanzacaftor/tezacaftor/deutivacaftor for 30 days prior to day 0
3. Diagnosis of CFRD with evidence of continued glucose intolerance at least 6 months after starting qualifying modulator therapy will be based upon one of the following:

   1. Insulin use
   2. Hemoglobin A1C \>6.5%
   3. Fasting glucose \>126 mg/dl
   4. Non-fasting glucose \>200 mg/dl (random or as part of a 2-hr OGTT)

Exclusion criteria:

1. Prior lung or liver transplant
2. Use of supplemental oxygen
3. BMI \<18
4. CF pulmonary exacerbation requiring hospitalization or intravenous antibiotics in the preceding 30 days
5. Systemic corticosteroid or regular non-steroidal anti-inflammatory use in the preceding 30 days
6. Cardiac, renal (creatinine clearance \<45 mL/minute), neurologic, psychiatric, endocrine or neoplastic diseases that are judged to interfere with participation in the study
7. Alanine aminotransferase, aspartate aminotransferase or alkaline phosphatase \>1.5X the upper limit of normal; bilirubin \>3 mg/dL
8. Taking medications that interact with metformin.
9. Vitamin B12 deficiency
10. Pregnancy or lactation
11. Inability or unwillingness to comply with an approved contraceptive method during the study period (females of childbearing age)
12. Use of medications known to be strong CYP inducers or moderate to strong CYP inhibitors
13. In the opinion of the investigator any severe or acute or chronic condition or laboratory abnormality that may increase the risk associated with trial participation or make the subject inappropriate for enrollment
14. Participation in another interventional trial that, in the opinion of the investigator, has the potential to affect the primary outcome

Where it's running

• University of Kansas Medical Center
  Kansas City, Kansas, United States Recruiting

Study contacts

• Principal investigator: Matthias A Salathe, M.D. — Professor
• Study coordinator: Matthias A Salathe, M.D.
• Email: msalathe@kumc.edu
• Phone: 9135886000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  This study is testing if using continuous glucose monitors can help better screen for diabetes in people with cystic fibrosis.

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• Investigating the impact of diet on diabetes risk in cystic fibrosis patients

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• Effects of a Low Glycemic Load Diet on Diabetes and Body Composition in Adults with Cystic Fibrosis

  This study is testing if a low glycemic load diet can help adults with cystic fibrosis-related diabetes manage their blood sugar and improve their overall health.

  Recruiting at 2 sites Rhode Island Hospital · Boston, Massachusetts and 1 other locations · NCT05723445

• Inhaled CFTR mRNA for cystic fibrosis in Chinese patients aged 12 and older

  This trial tests inhaled BMD003, a CFTR mRNA therapy, to see if it's safe and shows early signs of benefit in Chinese people 12 years and up with cystic fibrosis.

  Recruiting Early Phase 1 Peking Union Medical College Hospital · Beijing, Beijing Municipality · NCT07485543

• VX-272 dose escalation in healthy adults

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• Prevalence of smoking, passive smoke exposure, and vaping among adults with cystic fibrosis

  This project will see how common smoking, exposure to secondhand smoke, and vaping are among adults with cystic fibrosis followed at the Strasbourg Adult CF Center.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.