Cystic FibrosisNCT04002882
Role of Body Fat Distribution in Metabolic and Pulmonary Decline in Cystic Fibrosis (ORBIT-CF)
An observational study of Cystic Fibrosis, run by Emory University at 2 sites in United States.
Trial summary
Nutrition and body composition, the amount of muscle and fat in the body, has a role in overall health. This study wants to learn more about how nutrition and body composition affects health outcomes like glucose tolerance and lung function in patients with cystic fibrosis (CF) who are ages 16-30 years old. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Jul 2019to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- CF inclusion criteria
- confirmed CF diagnosis based on sweat testing by pilocarpine iontophoresis and/or CFTR genotyping with two disease causing mutations
- be aged ≥ 16 yrs
- clinically stable, defined as no changes in medical regimen (including medications) for at least 21 days prior to study visit
- participation in the CFF Patient Registry
- Longitudinal study inclusion:
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- CF participants who have normal glucose tolerance results after their initial study oral glucose tolerance test (OGTT).
- Healthy controls inclusion criteria:
- male or female ages 16 years and older
- clinically stable. Healthy controls will be recruited who are similar in age, gender, and BMI as the participants with CF.
Who cannot join
- CF exclusion criteria:
- diagnosis of CF-related diabetes (CFRD)
- nocturnal tube feeds
- life expectancy <6 months
- history of or on waiting list for lung transplant
- un-removable metal that is incompatible with MRI
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- inability or unwillingness to perform major study activities (OGTT, DEXA, MRI) due to claustrophobia, fear of blood draw, or other reasons
- current pregnancy or lactation
- study visit falls between window of 1 week to 8 weeks of initiation of CFTR modulator
- use of chronic oral corticosteroids,
- in the opinion of the CF Care Team or study physician, participant should not participate in the study, or
- inability to provide informed consent or assent.
- Healthy controls exclusion criteria:
- malignant neoplasm (other than localized basal cell cancer of the skin) during the previous 5 years
- respiratory (including asthma), endocrine (including diabetes), autoimmune, or other chronic disease
- HIV or other chronic infection
- current use of any medications to treat an acute or chronic disease or illness (anti-depressants, anti-anxiety medications are acceptable),
- acute illness within the past 3 weeks
- intravenous or oral antibiotics or use of systemic corticosteroids within the past 3 weeks
- inability or unwillingness to perform major study activities due to claustrophobia, fear of blood draw, or other reasons
- current pregnancy or lactation, or
- inability to provide informed consent or assent.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Emory University/Children's Hospital of Atlanta (CHOA)
Atlanta, Georgia, 30322
Jessica Alvarez, PhD, RD, 404-727-1390, jessica.alvarez@emory.edu
- Not yet recruiting
University of Alabama at Birmingham (UAB)/Children's of Alabama
Birmingham, Alabama, 35233
Michael Stalvey, MD, (205) 638-9107
About this study
Official title: Outcomes Related to Body Composition in Teens and Adults With Cystic Fibrosis (ORBIT-CF)
Nutrition and body composition, the amount of muscle and fat in the body, has a role in overall health. This study wants to learn more about how nutrition and body composition affects health outcomes like glucose tolerance and lung function in patients with cystic fibrosis (CF) who are ages 16-30 years old. 60 adolescents and young adults with CF will be recruited, and 30 volunteers without cystic fibrosis. A total of 40 of these study participants with CF will be asked to return for annual study visits for 2 years after the first visit.
The long-term goal of this study is to use the information collected to make decisions about future nutrition monitoring and interventions which help maintain optimal health for individuals with CF.
Read the detailed description
This is a prospective, observation study to test the central hypothesis that individuals with cystic fibrosis (CF) have a higher propensity to increased visceral adipose tissue (VAT) accumulation and decreased lean body mass (LBM) compared to healthy controls, and this dysregulation in adipose and protein deposition exacerbates glucose intolerance and lung function decline. A sub-set of participants with CF will be followed longitudinally for two years (n=40). The investigators will conduct detailed body composition, fat distribution, metabolic, and nutritional phenotyping in this cohort. Body fat distribution will be assessed with MRI. Whole body composition will be assessed with DEXA. Glucose tolerance will be assessed with an oral glucose tolerance test (OGTT) and mathematical modeling of the C-peptide and insulin response to glucose. Lung health will be assessed by objective clinical data and self-reported symptoms.
- Conditions
- Cystic Fibrosis
- Medical subject headings
- Cystic Fibrosis
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 |
|---|---|---|
| Subjects with Cystic Fibrosis | n=60 patients with CF ages 16-30 | |
| Healthy Controls | n=30 healthy controls matched to participants with CF for age, sex, BMI, and race. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visceral Adipose Tissue volume (VAT) by Magnetic Resonance Imaging (MRI)
Body fat distribution and body composition in 60 individuals with Cystic Fibrosis (CF) and 30 matched, healthy control will be assessed by Magnetic Resonance Imaging (MRI)
Measured: Baseline, 1 year, 2 year
Change in Disposition Index
The disposition index (DI) is a measure of the ability of B-cells to compensate for insulin resistance.
A lower DI indicates a loss of B-cell function, which means decreased pancreatic function. The disposition index will be assessed with an oral glucose tolerance test (OGTT) and mathematical modeling of the C-peptide and insulin response to glucose.
This study seeks to determine if glucose intolerance is associated with body composition and fat distribution in CF subjects.
Measured: Baseline, 1 year, 2 year
Change in Forced Expiratory Volume in the first second (FEV1%)
Clinical spirometry is a test of lung function that will be used to assess the progression of lung disease with the baseline Forced Expiratory Volume (FEV%) predicted within the past year. Baseline is defined as the average of the best FEV1% for each quarter of the calendar year. FEV1% predicted is a method of determining the severity of pulmonary disease and declines as disease severity increases.
Measured: Baseline, 1 year, 2 year
Secondary outcomes (9)
Change in Pancreatic lipid
Pancreatic lipid contributes to the Visceral Adipose Tissue volume (VAT) and it will me measured with the magnetic resonance imaging (MRI).
Participants will lay in the supine position for approximately 30 minutes while in the MRI scanner, and images of the abdominal area (L1-L5 vertebrae) and thigh area will be obtained. Images will later be analyzed for quantification of VAT volume and lipid content of pancreas will be analyzed
Measured: Baseline, 1 year, 2 year
Change in Hepatic lipid
Hepatic lipid contributes to the Visceral Adipose Tissue volume (VAT) and it will me measured with the MRI.
Participants will lay in the supine position for approximately 30 minutes while in the MRI scanner, and images of the abdominal area (L1-L5 vertebrae) and thigh area will be obtained. Images will later be analyzed for quantification of VAT volume and lipid content of liver will be analyzed
Measured: Baseline, 1 year, 2 year
Change in Thigh perimuscular adipose tissue (PMAT)
Thigh PMAT contributes to the VAT and it will me measured with the MRI. Participants will lay in the supine position for approximately 30 minutes while in the MRI scanner, and images of the abdominal area (L1-L5 vertebrae) and thigh area will be obtained. Images will later be analyzed for quantification of VAT volume and Thigh PMAT
Measured: Baseline, 1 year, 2 year
Change in Body Composition Analysis
Dual-energy X-ray absorptiometry (DEXA) is an imaging technique that provides whole body and regional estimates of the three main body components: fat, lean soft tissues and bone mineral mass.
Measured: Baseline, 1 year, 2 year
Change in Insulin secretion
Insulin secretion measures the total beta cell response (PhiTot), and will be assessed with an oral glucose tolerance test (OGTT).
Fasted blood samples will be drawn 30 minutes and 15 minutes before the initiation of glucose consumption. At time "zero", an oral glucose solution at the dose of 1.75 gm/kg to a maximum of 75 gms will be provided and consumed within 5 minutes of administration. Subsequent blood samples will be drawn at 10, 20, 30, 60, 90, and 120 min following initiation of glucose ingestion.
Decreased insulin secretion has been associated with lower B-cell function.
Measured: Baseline, 1 year, 2 year
Change in Whole body insulin sensitivity index (WBISI)
Insulin sensitivity describes how sensitive the body is to the effects of insulin. Whole body insulin sensitivity index (WBISI) is derived from glucose and insulin levels from the full length of the OGTT. The index is calculated using a formula.
Decreased insulin sensitivity index is associated with more advanced CF disease.
Measured: Baseline, 1 year, 2 year
Annual rate of Forced Expiratory Volume in the first second (FEV1%) decline
FEV1 is the maximal amount of air you can forcefully exhale in one second. It is then converted to a percentage of normal, based on your height, weight, and race.
It is assessed when doing the spirometry.
Measured: Baseline, 1 year, 2 year
Number of pulmonary exacerbations needing intravenous (IV) antibiotics within previous five years
Number of pulmonary exacerbations needing intravenous (IV) antibiotics within previous five years will be recorded.
Measured: Baseline
Number of Perceived respiratory symptoms measured with the Cystic Fibrosis Questionnaire-Revised (CFQ-R)
The Cystic Fibrosis Questionnaire-Revised (CFQ-R) is a disease-specific instrument, designed to measure impact on overall health, daily life, perceived well-being and symptoms.
Scores range from 0 to 100, with higher scores indicating better health.
Measured: Baseline, 1 year, 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start8 Jul 2019
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Responsible party
- Principal investigator, Jessica Alvarez, Emory University
- Investigators
- Jessica A Alvarez, PhD, RD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04002882
- Sponsor's protocol ID
- IRB00110358
- Status last verified
- May 2026
- First submitted
- 27 Jun 2019
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Completely de-identified participant data will be shared after publication of all results.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes Related to Body Composition in Teens and Adults With Cystic Fibrosis (ORBIT-CF)
- ClinicalTrials.gov ID
- NCT04002882
- Acronym / sponsor ID
- IRB00110358
- Conditions
- Cystic Fibrosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Study start
- 8 Jul 2019 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 1 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nutrition and body composition, the amount of muscle and fat in the body, has a role in overall health. This study wants to learn more about how nutrition and body composition affects health outcomes like glucose tolerance and lung function in patients with cystic fibrosis (CF) who are ages 16-30 years old. 60 adolescents and young adults with CF will be recruited, and 30 volunteers without cystic fibrosis. A total of 40 of these study participants with CF will be asked to return for annual study visits for 2 years after the first visit.
The long-term goal of this study is to use the information collected to make decisions about future nutrition monitoring and interventions which help maintain optimal health for individuals with CF.
Detailed description
This is a prospective, observation study to test the central hypothesis that individuals with cystic fibrosis (CF) have a higher propensity to increased visceral adipose tissue (VAT) accumulation and decreased lean body mass (LBM) compared to healthy controls, and this dysregulation in adipose and protein deposition exacerbates glucose intolerance and lung function decline. A sub-set of participants with CF will be followed longitudinally for two years (n=40). The investigators will conduct detailed body composition, fat distribution, metabolic, and nutritional phenotyping in this cohort. Body fat distribution will be assessed with MRI. Whole body composition will be assessed with DEXA. Glucose tolerance will be assessed with an oral glucose tolerance test (OGTT) and mathematical modeling of the C-peptide and insulin response to glucose. Lung health will be assessed by objective clinical data and self-reported symptoms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with Cystic Fibrosis | – | –n=60 patients with CF ages 16-30 |
| Healthy Controls | – | –n=30 healthy controls matched to participants with CF for age, sex, BMI, and race. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (10 listed)
- CF inclusion criteria
- confirmed CF diagnosis based on sweat testing by pilocarpine iontophoresis and/or CFTR genotyping with two disease causing mutations
- be aged ≥ 16 yrs
- clinically stable, defined as no changes in medical regimen (including medications) for at least 21 days prior to study visit
- participation in the CFF Patient Registry
Key exclusion criteria (22 listed)
- diagnosis of CF-related diabetes (CFRD)
- nocturnal tube feeds
- life expectancy <6 months
- history of or on waiting list for lung transplant
- un-removable metal that is incompatible with MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Visceral Adipose Tissue volume (VAT) by Magnetic Resonance Imaging (MRI)
Time frame: Baseline, 1 year, 2 year
Body fat distribution and body composition in 60 individuals with Cystic Fibrosis (CF) and 30 matched, healthy control will be assessed by Magnetic Resonance Imaging (MRI)
Change in Disposition Index
Time frame: Baseline, 1 year, 2 year
The disposition index (DI) is a measure of the ability of B-cells to compensate for insulin resistance. A lower DI indicates a loss of B-cell function, which means decreased pancreatic function. The disposition index will be assessed with an oral glucose tolerance test (OGTT) and mathematical modeling of the C-peptide and insulin response to glucose. This study seeks to determine if glucose intolerance is associated with body composition and fat distribution in CF subjects.
Change in Forced Expiratory Volume in the first second (FEV1%)
Time frame: Baseline, 1 year, 2 year
Clinical spirometry is a test of lung function that will be used to assess the progression of lung disease with the baseline Forced Expiratory Volume (FEV%) predicted within the past year. Baseline is defined as the average of the best FEV1% for each quarter of the calendar year. FEV1% predicted is a method of determining the severity of pulmonary disease and declines as disease severity increases.
9 secondary outcomes
Change in Pancreatic lipid
Time frame: Baseline, 1 year, 2 year
Change in Hepatic lipid
Time frame: Baseline, 1 year, 2 year
Change in Thigh perimuscular adipose tissue (PMAT)
Time frame: Baseline, 1 year, 2 year
Change in Body Composition Analysis
Time frame: Baseline, 1 year, 2 year
Change in Insulin secretion
Time frame: Baseline, 1 year, 2 year
Change in Whole body insulin sensitivity index (WBISI)
Time frame: Baseline, 1 year, 2 year
Annual rate of Forced Expiratory Volume in the first second (FEV1%) decline
Time frame: Baseline, 1 year, 2 year
Number of pulmonary exacerbations needing intravenous (IV) antibiotics within previous five years
Time frame: Baseline
Number of Perceived respiratory symptoms measured with the Cystic Fibrosis Questionnaire-Revised (CFQ-R)
Time frame: Baseline, 1 year, 2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: Yes. Completely de-identified participant data will be shared after publication of all results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jessica A Alvarez, PhD, RD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Swati Zaveri, PhD (440-778-8373, swati.shital.zaveri@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visceral Adipose Tissue volume (VAT) by Magnetic Resonance Imaging (MRI) (time frame: Baseline, 1 year, 2 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.