Cystic Fibrosis Related DiabetesNCT07102043
Glucose Metabolism in Cystic Fibrosis Related Diabetes (CFRD)
An observational study of Cystic Fibrosis Related Diabetes, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Cystic Fibrosis Related Diabetes
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2026to 28 May 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with Cystic Fibrosis related Diabetes (CFRD) Subjects will be recruited from the UAB Health System. Primary locations for recruitment will include the CF center and pulmonary clinics and endocrinology clinics. Dr. Solomon is the Associate Director of the CF center and the Co-Director of the Clinical Research Unit. He will work with the clinical provider team of the adult CF clinic to find eligible patients. All physical recruitment locations are within 5-30 minutes walking/driving distance from the UAB Clinical Research Unit (CRU). Dr. A. Basu, is Director of the Diabetes Technology Clinic at UAB and he sees many of these patients for diabetes care; we also have open communication with the endocrinology and primary care clinics at UAB, where we have had success in the past recruiting for previous and current ongoing studies. Electronically, we will recruit through the UAB Hospital electronic medical record (EMR) system, and UAB internet p
Who may be able to join
- 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.
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- 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:
Who cannot join
- 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
- Pregnancy
- 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:
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 352294
About this study
Official title: Glucose Metabolism in CFRD: Exploring the Role of CFTR Modulators in Metabolic Dysfunction
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.
Read the detailed description
This is a mechanistic observational study. It is NOT a clinical trial. A physiological challenge of a single mixed meal tolerance test (MMTT) is administered, which will enable a comprehensive assessment of multiple parameters of glucose turnover, insulin secretion, insulin sensitivity and lipolysis in individuals with CFRD. The MMTT is the gold standard for measuring both insulin action and secretion simultaneously with glucose kinetics. The pilot 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).
We plan to gather critical preliminary data on the following aspects of CFRD:
- Abnormalities in specific components (basal vs. static vs. dynamic) of beta-cell function in CFRDF508del+ETI and in CFRD-ETI individuals.
- Effects of ETI on components of beta cell function.
- Effects of CFTR mutation and of CFTR modulators (CFRDF508del+ETI) on insulin sensitivity and post prandial glucose turnover in CFRD.
- Conditions
- Cystic Fibrosis Related Diabetes
- Keywords
- Cystic Fibrosis Related Diabetes, cystic fibrosis transmembrane conductance regulator (CFTR), CFTR modulators, Elexacaftor/ tezacaftor/ivacaftor or ETI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CFRD F508del +ETI | CFRD with at least one copy of F508del currently on elexacaftor/tezacaftor/ivacaftor (CFRDF508del+ETI), | |
| CFRD-ETI | CFRD with a mutation that is not eligible for modulator therapy (CFRD-ETI). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disposition Index in CFRD
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).
Measured: Day 1 During the Mixed meal test
Secondary outcomes (1)
Post prandial glucose turnover
Post prandial glucose turnover is improved in CFRDF508del+ETI when compared to CFRD with a mutation not eligible to be on ETI (CFRD-ETI).
Measured: Day 1 During the mixed meal test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start28 May 2026
- Primary completion1 May 2028 (estimated)
- Study completion28 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis Related DiabetesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rita Basu, University of Alabama at Birmingham
- Investigators
- Rita Basu, MD, Principal investigator, UAB Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07102043
- Sponsor's protocol ID
- IRB300014949
- Other IDs
- P30DK072482
- Status last verified
- Jul 2026
- First submitted
- 17 Jun 2025
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared, however cumulative data from all participants will be made available on completion of study as per NIH data sharing policy.