Strength and Muscle Related Outcomes for Nutrition and Lung Function in CF

Status: Recruiting
Location: See all (24) locations...
Intervention Type: Other, Diagnostic test, Device
Study Type: Observational
SUMMARY

The goal of the study is to examine multiple markers of anthropometrics, body composition, sarcopenia and frailty and compare them to dual energy X-ray absorptiometry (DXA) output, which is considered the current clinical gold-standard tool to measure body composition. The result of this study will provide detailed data regarding the nutrition and body composition within this Cystic Fibrosis population and also provide a baseline evaluation for use of these biomarkers in the future studies including evaluation of nutritional intervention. Further, the study will also include psychosocial and other patient-reported outcomes and medical contributors to understand their contributions to the nutritional failure in the adult advanced lung disease population. Finally, the study will evaluate both established and emerging nutritional and body composition parameters and link them to clinical outcomes in adults with CF across the spectrum of pulmonary function.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Cohort 1: Participants are eligible if their percentage of predicated forced expiratory volume in 1 second (ppFEV1) is \<70% during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation)

• Cohort 2: Participants are eligible if their percentage of predicted forced expiratory volume in 1 second (ppFEV1) is 70% or greater during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).

• Both cohorts match by age, gender, race and CFTR genotype severity.

Locations
United States
Arkansas
University of Arkansas for Medical Sciences (UAMS)
RECRUITING
Little Rock
Arizona
University of Arizona
RECRUITING
Tucson
Connecticut
Yale University School of Medicine
NOT_YET_RECRUITING
New Haven
Georgia
Emory
RECRUITING
Atlanta
Iowa
University of Iowa
NOT_YET_RECRUITING
Iowa City
Illinois
Northwestern University
RECRUITING
Chicago
Kentucky
University of Kentucky
RECRUITING
Lexington
Louisiana
Tulane University
NOT_YET_RECRUITING
New Orleans
Massachusetts
Boston Children's Hospital and Brigham and Women's CF Center
RECRUITING
Boston
Massachusetts General Hospital (MGH)
RECRUITING
Boston
Maryland
John Hopkins University
RECRUITING
Baltimore
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Missouri
Washington University School of Medicine (St. Louis)
RECRUITING
St Louis
New Jersey
Rutgers Health
RECRUITING
New Brunswick
New York
New York Medical College (NYMC)
RECRUITING
Hawthorne
Northwell LIJ Adult Cystic Fibrosis Center
NOT_YET_RECRUITING
New Hyde Park
Ohio
University of Cincinnati
RECRUITING
Cincinnati
University Hospitals
RECRUITING
Cleveland
Oklahoma
University of Oklahoma Sciences Center
RECRUITING
Oklahoma City
Oregon
Oregon Health and Science University
RECRUITING
Portland
Pennsylvania
University of Pittsburgh Medical Center
RECRUITING
Pittsburgh
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Texas
Baylor University
NOT_YET_RECRUITING
Houston
Virginia
University of Virginia Cystic Fibrosis Center
RECRUITING
Charlottesville
Contact Information
Primary
Judy Sibayan
jsibayan@jaeb.org
(813) 975-8690
Time Frame
Start Date: 2023-04-20
Estimated Completion Date: 2028-12
Participants
Target number of participants: 300
Treatments
Cohort 1
Forced expiratory volume in 1 second (FEV1) \<70% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation). If no stable spirometry data are available in the 12 months prior to enrollment, from the prior 24 months will be used.
Cohort 2
FEV1 ≥70% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).
Related Therapeutic Areas
Sponsors
Leads: Jaeb Center for Health Research

This content was sourced from clinicaltrials.gov