Metformin for People With CFRD on CFTR Modulator Therapy to Improve Ion Channel Function

Part of paid clinical trials in Kansas City, Kansas.

Sponsor
University of Kansas Medical Center
Study ID
NCT04530383
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cystic Fibrosis
  • Cystic Fibrosis-related Diabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Metformin Hydrochloride — DRUG
    1000 mg twice daily

Study Details

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)

Key Dates

Start date
Feb 14, 2022
Status verified
Apr 2026
Primary completion
Dec 30, 2027
Completion
Jul 15, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Metformin dose regimen A
    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.

Primary Outcome Measure

Change in BK channel gene expression [ Time Frame: Baseline through week 14 of metformin treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Kansas Medical CenterKansas CityKansas66160
Matthias A Salathe, M.D.
[email protected]
9135886000
Carolina Aguiar
9139459295
Charles D Bengtson, M.D. (SUB_INVESTIGATOR)
Andreas Schmid, M.D. (SUB_INVESTIGATOR)

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By research site
University of Kansas Medical Center· Kansas City, KS

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