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Role of Body Fat Distribution in Metabolic and Pulmonary Decline in Cystic Fibrosis (ORBIT-CF)

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	16 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

CF inclusion criteria. 1. confirmed CF diagnosis based on sweat testing by pilocarpine iontophoresis and/or cystic fibrosis trans membrane genotyping (CFTR) with two disease causing mutations. 2. pancreatic exocrine insufficiency. 3. ages 16 years and older. 4. clinically stable, defined as no changes in medical regimen (including medications) for at least 21 days prior to study visit. 5. baseline FEV1% predicted ≥40% where baseline is defined as the average of the best FEV1% for each quarter of the calendar year. 6. participation in the Cystic Fibrosis Foundation (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. 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. 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. 9. inability to provide informed consent or assent.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04002882
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Emory University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jessica A Alvarez, PhD, RD
Principal Investigator Affiliation	Emory University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Cystic Fibrosis

Additional Details

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.

Arms & Interventions

Arms

: 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.

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Birmingham, Alabama

Status

Not yet recruiting

Address

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

Birmingham, Alabama, 35233

Site Contact

Michael Stalvey, MD

[email protected]

205-638-9107

Atlanta, Georgia

Status