Cystic fibrosis study probes link between body fat, muscle, and lung health

NCT ID NCT04002882

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
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 Results may not be published yet.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

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Status unknown
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First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at how the amount of muscle and fat in the body affects glucose tolerance and lung function in people aged 16-30 with cystic fibrosis. Researchers will use MRI scans and glucose tests to track changes over two years. The goal is to use this information to improve nutrition care for people with CF.

What this could mean

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

What this could lead to
If successful, this study could guide future nutrition monitoring and interventions to help maintain optimal health for people with cystic fibrosis.
What could go wrong
This is an observational study, not a treatment trial. It may not lead to direct health improvements, and results may not apply to all ages or severities of cystic fibrosis.

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 90 people

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

Started

Jul 2019

Expected to finish

May 2027

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

This will be a two-site study of n=60 patients with CF ages 16 years and older and n=30 age-, sex-, BMI-, and race-matched healthy controls. As a sub-study, 40 of these CF subjects will be followed longitudinally and assessed annually for two years.

Ages

16 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: CF inclusion criteria 1. confirmed CF diagnosis based on sweat testing by pilocarpine iontophoresis and/or CFTR genotyping with two disease causing mutations 2. be aged ≥ 16 yrs 3. clinically stable, defined as no changes in medical regimen (including medications) for at least 21 days prior to study visit 4. participation in the CFF Patient Registry Longitudinal study inclusion: CF participants who have normal glucose tolerance results after their initial study oral glucose tolerance test (OGTT). Healthy controls inclusion criteria: 1. male or female ages 16 years and older 2. clinically stable. Healthy controls will be recruited who are similar in age, gender, and BMI as the participants with CF. Exclusion Criteria: CF exclusion criteria: 1. diagnosis of CF-related diabetes (CFRD) 2. nocturnal tube feeds 3. life expectancy \<6 months 4. history of or on waiting list for lung transplant 5. un-removable metal that is incompatible with MRI 6. inability or unwillingness to perform major study activities (OGTT, DEXA, MRI) due to claustrophobia, fear of blood draw, or other reasons 7. current pregnancy or lactation 8. study visit falls between window of 1 week to 8 weeks of initiation of CFTR modulator 9. use of chronic oral corticosteroids, 10. in the opinion of the CF Care Team or study physician, participant should not participate in the study, or 11. inability to provide informed consent or assent. Healthy controls exclusion criteria: 1. malignant neoplasm (other than localized basal cell cancer of the skin) during the previous 5 years 2. respiratory (including asthma), endocrine (including diabetes), autoimmune, or other chronic disease 3. HIV or other chronic infection 4. current use of any medications to treat an acute or chronic disease or illness (anti-depressants, anti-anxiety medications are acceptable), 5. acute illness within the past 3 weeks 6. intravenous or oral antibiotics or use of systemic corticosteroids within the past 3 weeks 7. inability or unwillingness to perform major study activities due to claustrophobia, fear of blood draw, or other reasons 8. current pregnancy or lactation, or 9. inability to provide informed consent or assent.

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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

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Emory University/Children's Hospital of Atlanta (CHOA)

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • University of Alabama at Birmingham (UAB)/Children's of Alabama

    NOT_YET_RECRUITING

    Birmingham, Alabama, 35233, United States

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