NCT07102043 · University of Alabama at Birmingham
Glucose Metabolism in Cystic Fibrosis Related Diabetes (CFRD)
What this study is about
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.
View original scientific description
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.
Primary outcome measures
Disposition Index in CFRD
Time frame: Day 1 During the Mixed meal test
Disposition Index (DI - β-cell responsivity appropriate to the degree of insulin resistance) is higher in CFRDF508del+ETI when compared to CFRD with a mutation not eligible to be on ETI (CFRD-ETI).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Diagnosis of Cystic Fibrosis Related Diabetes (CFRD)
- 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 preferably on insulin pump therapy (i.e., SAP, HCL) with or without CGM will be recruited. However, use of MDI (Multiple Daily Injections) of insulin, i.e., on basal-bolus insulin therapy will also be included. Most of our patients are on insulin therapy with very few on oral antidiabetes medications but we would like to offer them the choice of participation.
- Subjects on FDA approved/recommended full doses of ETI will be offered participation. If dose adjustments of ETI are made after enrollment a discussion will be done with the primary care provider and HCSTOC as required.
- 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 Subjects meeting any of the
Exclusion criteria
- at baseline will be excluded from study participation: Exclusion Criteria:
- Debilitating chronic disease
- Anemia \<10.0 gm/dL in females and \<11.0 gm/dL in males
- Symptoms of undiagnosed illness on history/exam
- Abuse of alcohol or recreational drugs
- Active hepatic disease (we will include only if less than 3X ULN for liver enzymes and no fibrosis on ultrasound). Transient elevations of liver enzymes will not exclude participation but will be discussed with the primary care provider and HCSTOC as required.
- Current use of the following drugs and supplements: i. Corticosteroids ii. Benzodiazepines iii. Opiates iv. Barbiturates v. Anticoagulant therapy vi. Any other medication that the investigator believes is a contraindication to the subject's participation
Where
- Birmingham, Alabama
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 24, 2026 · Source of record for eligibility and locations