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

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: t
View:

⁃ 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:

⁃ 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.

Locations
United States
Alabama
University of Alabama at Birmingham (UAB)/Children's of Alabama
NOT_YET_RECRUITING
Birmingham
Georgia
Emory University/Children's Hospital of Atlanta (CHOA)
RECRUITING
Atlanta
Contact Information
Primary
Swati Zaveri, PhD
swati.shital.zaveri@emory.edu
440-778-8373
Backup
Jessica A Alvarez, PhD, RD
jessica.alvarez@emory.edu
4047271390
Time Frame
Start Date: 2019-07-08
Estimated Completion Date: 2026-05
Participants
Target number of participants: 90
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Cystic Fibrosis Foundation
Leads: Emory University

This content was sourced from clinicaltrials.gov