TERMINATED

Effects of Metformin on Airway Ion Channel Dysfunction in Cystic Fibrosis-related Diabetes

Conditions

Cystic Fibrosis-related Diabetes Cystic Fibrosis Metformin

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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

The purpose of this study is to assess the efficacy of metformin to improve airway ion channel function in those with CF-related diabetes (CFRD)

Official Title

A Randomized, Double-blind, Crossover Clinical Trial of Metformin in Those With CFRD on CFTR Modulator Therapy to Improve Ion Channel Function

Quick Facts

Study Start:2022-02-14

Study Completion:2025-07-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT04530383

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 Criteria	Exclusion Criteria
1. Age \>18 years with a prior diagnosis of CF. 2. Use of ivacaftor or elexacaftor/tezacaftor/ivacaftor for 30 days prior to day 0 3. 3\. Diagnosis of CFRD with evidence of continued glucose intolerance at least 6 months after starting elexacaftor/tezacaftor/ivacaftor 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)	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

Inclusion Criteria

Exclusion Criteria

1. Age \>18 years with a prior diagnosis of CF.
2. Use of ivacaftor or elexacaftor/tezacaftor/ivacaftor for 30 days prior to day 0
3. 3\. Diagnosis of CFRD with evidence of continued glucose intolerance at least 6 months after starting elexacaftor/tezacaftor/ivacaftor 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)

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

Contacts and Locations

Principal Investigator

Matthias A Salathe, M.D.

PRINCIPAL_INVESTIGATOR

Professor

Study Locations (Sites)

University of Kansas Medical Center

Kansas City, Kansas, 66160

United States

Collaborators and Investigators

Sponsor: University of Kansas Medical Center

Matthias A Salathe, M.D., PRINCIPAL_INVESTIGATOR, Professor

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 Date2022-02-14

Study Completion Date2025-07-09

Study Record Updates

Study Start Date2022-02-14

Study Completion Date2025-07-09

Terms related to this study

Keywords Provided by Researchers

Metformin

Additional Relevant MeSH Terms

Cystic Fibrosis-related Diabetes
Cystic Fibrosis