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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Arizona
Tucson, Arizona, United States
University of Arkansas for Medical Sciences (UAMS)
Little Rock, Arkansas, United States
Emory
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
University of Kentucky
Lexington, Kentucky, United States
Tulane University
New Orleans, Louisiana, United States
John Hopkins University
Baltimore, Maryland, United States
Massachusetts General Hospital (MGH)
Boston, Massachusetts, United States
Boston Children's Hospital and Brigham and Women's CF Center
Boston, Massachusetts, United States
Start Date
April 20, 2023
Primary Completion Date
December 1, 2028
Completion Date
December 1, 2028
Last Updated
March 13, 2026
300
ESTIMATED participants
BMI and lean mass index from DXA
DIAGNOSTIC_TEST
Anthropometric Measurements
DIAGNOSTIC_TEST
Hand-grip strength
DIAGNOSTIC_TEST
Six-minute walk Test
DIAGNOSTIC_TEST
Sit-to-Stand Test
DIAGNOSTIC_TEST
Short physical performance battery (SPPB)
DIAGNOSTIC_TEST
BIA Sub-study
DIAGNOSTIC_TEST
Accelerometry to assess physical activity
DIAGNOSTIC_TEST
Gastrointestinal (GI) and nutrition questionnaires:
OTHER
Psychosocial questionnaire: PHQ-8
OTHER
Psychosocial questionnaire: GAD-7
OTHER
Psychosocial questionnaire: The Treatment Self-Regulation Questionnaire (TSRQ)
OTHER
Psychosocial questionnaire: CF Fatalism Scale
OTHER
Psychosocial questionnaire: Body Esteem Scale for Adolescents and Adults (BESAA)
OTHER
12-month Questionnaire
OTHER
Oral glucose tolerance testing (OGTT)
OTHER
Continuous glucose monitoring (CGM)
DEVICE
Chest CT scans (When available within the past 6 months in medical records)
DIAGNOSTIC_TEST
Hologic Dual X-Ray Absorptiometry (DXA)
DIAGNOSTIC_TEST
Ultrasound Sub-study of assessment of appendage muscles using ultrasound
DIAGNOSTIC_TEST
Psychosocial questionnaire: Hunger Vital Sign questionnaire
DIAGNOSTIC_TEST
Respiratory symptom questionnaire: CRISS
OTHER
Spirometry
DIAGNOSTIC_TEST
Psychosocial questionnaire: Additional Health Questionnaire
OTHER
CF Management Questionnaire
OTHER
Food Frequency Questionnaire
OTHER
Lead Sponsor
Jaeb Center for Health Research
NCT02417740
NCT06616857
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07108153