Glucose Metabolism in Cystic Fibrosis Related Diabetes (CFRD) (NCT07102043) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Glucose Metabolism in Cystic Fibrosis Related Diabetes (CFRD)
United States30 participantsStarted 2026-04-01
Plain-language summary
The study aims to test whether use of CFTR modulators (ETI) improves fasting and post prandial glycemia by enhancing disposition index (DI) in individuals with CFRD with CFTR +ve mutation (at least one copy of F508del) on CFTR modulator (ETI) therapy (CFRDF508del+ETI). CFRD with a mutation that is not eligible for modulator therapy (CFRD-ETI) will be the control group.
Who can participate
Age range21 Years – 75 Years
SexALL
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Inclusion Criteria:
* Individuals who have at least one copy of the F508 deletion and are on ETI medications and individuals who have a different mutation and are not eligible for ETI medications
* Age 21-75 years at time of consent
* BMI 19-50 kg/m2 (In Asians BMI is \~ 2 points lower for comparison so it is 17-48 kg/m2)
* Creatinine ≤ 1.4 mg/dl in women and ≤ 1.5 mg/dl in men
* HbA1c ≤ 11% lifestyle treatment or mono/combination therapy with oral hypoglycemic agents (e.g. metformin or sulphonylurea or SGLT2i) and/or insulin.
* Willing to be at a stable weight for duration of the study.
* An understanding of and willingness to follow the protocol and sign the informed consent
Exclusion Criteria:
* Debilitating chronic disease
* Anemia \<10 gm/dL in females and \<11.0 gm/dL in males
* Symptoms of undiagnosed illness on history/exam
* Abuse of alcohol or recreational drugs
* Pregnancy
* Active hepatic disease
* Current use of the following drugs and supplements: corticosteroids, benzodiazepines, opiates, barbiturates, anticoagulant therapy
* Any other medication that the investigator believes is a contraindication to the subject's participation