An Open Label Clinical Trial of Metformin in Those With CFRD on CFTR Modulator Therapy to Improve Ion Channel Function
University of Kansas Medical Center
Summary
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)
Description
Up to 30 patients with CFRD on highly effective CFTR modulator therapy who meet criteria and agree to participation in the study will be placed on metformin. There will be a dose-escalation starting with 500mg twice daily for a week, followed by 500mg in the AM and 1000mg in the PM for another week and finally followed by 1000mg twice daily for 14 weeks. To minimize risk of B12 deficiency, a known side effect of long-term metformin use, we will also provide a supplement of 1000 μg oral cyanocobalamin daily for the duration of the trial
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 oxyg…
Interventions
- DrugMetformin Hydrochloride
1000 mg twice daily
Location
- University of Kansas Medical CenterKansas City, Kansas