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.
Conditions
Cystic Fibrosis
Recruitment Status
Recruiting
Eligibility Criteria
Inclusion Criteria:
Cohort 1: Patients are eligible if their percentage of predicated forced expiratory volume in1 second (FEV1) is 60% or lower at screening.
Cohort 2: Patients are eligible if their percentage of predicted forced expiratory volume in 1 second (FEV1) is 60% or greater at screening.
Both cohorts match by age, gender, race and CFTR genotype severity.
Exclusion Criteria:
No prior solid organ transplantation
No initiation of an investigation drug within 28 days prior to and including Visit 1
No initiation of new chronic therapy (e.g., ibuprofen, azithromycin, inhaled tobramycin, Cayston, CFTR modulator) within 28 days prior to and including Visit 1.
No acute use of antibiotics (oral, inhaled or IV) or acute use of systemic corticosteroids for respiratory tract symptoms within 14 days prior to and including Visit 1.
For the BIA sub-study - Individuals with an implanted pacemaker will be excluded.
No initiation of a drug for weight loss (such as a GLP-1 receptor agonist) or bariatric surgery within 6-months prior to and including the Baseline visit.
Patients with continued rapid change or extreme GI symptoms related to weight loss therapy should be excluded at the discretion of the study investigator.
Intervention
Intervention Type
Intervention Name
Diagnostic Test
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
Other
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)
Device
Continuous glucose monitoring (CGM)
Diagnostic Test
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
Other
Respiratory symptom questionnaire: CRISS
Diagnostic Test
Spirometry
Other
Psychosocial questionnaire: Additional Health Questionnaire
Gender
All
Min Age
18 Years
Max Age
N/A
Download Date
February 13, 2024
Principal Investigator
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Primary Contact Information
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: