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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Emory University
Study ID
NCT04002882
Status
Recruiting
Apply to this trial

Conditions

  • Cystic Fibrosis

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Jul 8, 2019
Status verified
May 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
90 participants (estimated)

Arms

  • Arm: Subjects with Cystic Fibrosis
    n=60 patients with CF ages 16-30
  • Arm: Healthy Controls
    n=30 healthy controls matched to participants with CF for age, sex, BMI, and race.

Primary Outcome Measure

Change in Visceral Adipose Tissue volume (VAT) by Magnetic Resonance Imaging (MRI) [ Time Frame: Baseline, 1 year, 2 year ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham (UAB)/Children's of AlabamaBirminghamAlabama35233
Michael Stalvey, MD
(205) 638-9107
Emory University/Children's Hospital of Atlanta (CHOA)AtlantaGeorgia30322
Jessica Alvarez, PhD, RD
[email protected]
404-727-1390

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham (UAB)/Children's of Alabama· Birmingham, ALEmory University/Children's Hospital of Atlanta (CHOA)· Atlanta, GA

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