NCT07102043Enrolling by invitation
Glucose Metabolism in Cystic Fibrosis Related Diabetes (CFRD)
Glucose Metabolism in CFRD: Exploring the Role of CFTR Modulators in Metabolic Dysfunction
Source: ClinicalTrials.gov · Last updated 3 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 17 Jun 2025
- Start date
- 28 May 2026
- Primary completion date
- 1 May 2028
- Lead sponsor
- University of Alabama at Birmingham
- Diseases
- Cystic fibrosis
- NCT number
- NCT07102043
What you commit to
- Study type: Observational
- Planned participants: 30
- From 28 May 2026 to the primary completion date, 1 May 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Abuse of alcohol or recreational drugs
- 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
Other illness
- Debilitating chronic disease
- Symptoms of undiagnosed illness on history/exam
Lab values
- 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.
Other
- Anemia \<10.0 gm/dL in females and \<11.0 gm/dL in males
- Pregnancy
Who the study is looking for
- 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:
Age in the registry: 21 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.