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

NCT04002882 | Recruiting

• 1 other identifier: IRB00110358
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (3)

• 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)

  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.

  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.

  Baseline, 1 year, 2 year

Secondary Outcomes (9)

• Change in Pancreatic lipid

  Baseline, 1 year, 2 year

• Change in Hepatic lipid

  Baseline, 1 year, 2 year

• Change in Thigh perimuscular adipose tissue (PMAT)

  Baseline, 1 year, 2 year

• Change in Body Composition Analysis

  Baseline, 1 year, 2 year

• Change in Insulin secretion

  Baseline, 1 year, 2 year

Study Arms (2)

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.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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
• CF participants who have normal glucose tolerance results after their initial study oral glucose tolerance test (OGTT).
• 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.

You may not qualify if:

• 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
• 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.
• 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),

Sponsors & Collaborators

• Emory University: lead
• Cystic Fibrosis Foundation: collaborator

Study Sites (2)

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

Birmingham, Alabama, 35233, United States

NOT YET RECRUITING

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

Atlanta, Georgia, 30322, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Specimens that remain after completion of the study will be stored for future studies beyond the scope of the current study only if subjects denote the appropriate section of the informed consent form to grant long term storage of samples. Specimens and data will be stored at Emory University within the PI's (Jessica Alvarez) laboratory. Any stored samples will be de-identified with a specific code whose identity can only be accessed by authorized study personnel appointed by the PI. During the conduct of the study, an individual participant can choose to withdraw consent to have biological specimens stored for future research. However, withdrawal of consent with regard to bio-sample storage may not be possible after the study is completed.

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Jessica A Alvarez, PhD, RD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Swati Zaveri, PhD

CONTACT

440-778-8373; swati.shital.zaveri@emory.edu

Jessica A Alvarez, PhD, RD

CONTACT

4047271390; jessica.alvarez@emory.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assitant professor

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: July 1, 2019
• Study Start: July 8, 2019
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months following publication of results. No end date.
• Access Criteria: Researchers who provide a methodologically sound proposal that is approved by all primary study co-investigators. Types of analyses: To achieve the aims in the approved proposal and for individual participant data-meta analysis. Proposals should be directed to Dr. Alvarez at jessica.alvarez@emory.edu

Locations

US (2)