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Can CF drugs tame diabetes in cystic fibrosis?

NCT ID NCT07102043

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 2 times

Summary

This study looks at whether CFTR modulators (ETI) help control blood sugar in people with cystic fibrosis-related diabetes (CFRD). Researchers will compare 30 adults with CFRD who take ETI to those who cannot take it. The goal is to see if the drug improves how the body handles sugar after meals.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CFTR modulator (elexacaftor/tezacaftor/ivacaftor, ETI)
What this could lead to
If successful, this could clarify whether CFTR modulators improve blood sugar regulation in cystic fibrosis-related diabetes, pointing toward better management strategies.
What could go wrong
This is a small observational study (30 people) measuring metabolic markers, not clinical outcomes. It may not prove direct benefit or apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

21 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Diagnosis of Cystic Fibrosis Related Diabetes (CFRD) 2. Age 21-75 years at time of consent 3. BMI 19-50 kg/m2 (In Asians BMI is \~ 2 points lower for comparison so it is 17-48 kg/m2) 4. Creatinine ≤ 1.4 mg/dl in women and ≤ 1.5 mg/dl in men 5. 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. 6. 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. 7. Willing to be at a stable weight for duration of the study. 8. 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: 1. Debilitating chronic disease 2. Anemia \<10.0 gm/dL in females and \<11.0 gm/dL in males 3. Symptoms of undiagnosed illness on history/exam 4. Abuse of alcohol or recreational drugs 5. Pregnancy 6. 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. 7. 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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  3. A doctor treating you

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Contacts and locations

Locations

  • University of Alabama at Birmingham

    Birmingham, Alabama, 352294, United States

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