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

Description

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

Study Overview

Study Details

Study overview

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.

Outcomes Related to Body Composition in Teens and Adults With Cystic Fibrosis (ORBIT-CF)

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

Condition
Cystic Fibrosis
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham (UAB)/Children's of Alabama, Birmingham, Alabama, United States, 35233

Atlanta

Emory University/Children's Hospital of Atlanta (CHOA), Atlanta, Georgia, United States, 30322

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

16 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Emory University,

Jessica A Alvarez, PhD, RD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

2025-05