Clinical trial NCT05639556: Strength and Muscle Related Outcomes for Nutrition and Lung Function in CF
Official title: Strength and Muscle Related Outcomes for Nutrition and Lung Function in CF
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cystic Fibrosis
Lead sponsor: Jaeb Center for Health Research
Sponsor class: OTHER
First posted: 2022-12-06
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include adults 18 and older with a confirmed diagnostic of cystic fibrosis, identified genotypes (when available), no prior solid organ transplant, and not pregnant or planning on becoming pregnant during the 1st year of the study. Participants receiving a lung transplantation while enrolled in the study will not need to be withdrawn.

Brief 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 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.

Primary outcomes:
measure: Correlation between DXA lean mass index and BMI
timeFrame: Baseline and 1 year
measure: Correlation between DXA lean mass index and mid-arm muscle circumference
timeFrame: Baseline and 1 year
measure: Correlation between DXA lean mass index and hand-grip strength
timeFrame: Baseline and 1 year
measure: Correlation between DXA lean mass index and the 6-minute walk distance traveled
timeFrame: Baseline and 1 year
measure: Correlation between DXA lean mass index and the 1-minute sit-to-stand number of repetitions
timeFrame: Baseline and 1 year
measure: Correlation between DXA lean mass index and Short Physical Performance Battery frailty score
timeFrame: Baseline and 1 year
Secondary outcomes:
measure: Characterize lean mass index from DXA cross-sectionally and longitudinally
timeFrame: Baseline and 1 year
measure: Characterize BMI cross-sectionally and longitudinally
timeFrame: Baseline and 1 year
measure: Characterize mid-arm measurement circumference cross-sectionally and longitudinally
timeFrame: Baseline and 1 year
measure: Characterize hand-grip strength cross-sectionally and longitudinally
timeFrame: Baseline and 1 year
measure: Characterize 1 minute sit-to-stand repetitions cross-sectionally and longitudinally
timeFrame: Baseline and 1 year
measure: Characterize mid-arm 6-minute walk test distance traveled cross-sectionally and longitudinally
timeFrame: Baseline and 1 year
measure: Characterize the Short Physical Performance Battery frailty score cross-sectionally and longitudinally
timeFrame: Baseline and 1 year
measure: Compare lean mass index from DXA between participants with FEV1 <60% to matched participants with FEV1 ≥60%
timeFrame: Baseline and 1 year
measure: Compare BMI between participants with FEV1 <60% to matched participants with FEV1 ≥60%
timeFrame: Baseline and 1 year
measure: Compare lean mass index from mid-arm muscle circumference between participants with FEV1 <60% to matched participants with FEV1 ≥60%
timeFrame: Baseline and 1 year
measure: Compare hand-grip strength between participants with FEV1 <60% to matched participants with FEV1 ≥60%
timeFrame: Baseline and 1 year
measure: Compare the 1-minute sit-to-stand repetitions between participants with FEV1 <60% to matched participants with FEV1 ≥60%
timeFrame: Baseline and 1 year
measure: Compare the 6-minute walk test distance between participants with FEV1 <60% to matched participants with FEV1 ≥60%
timeFrame: Baseline and 1 year
measure: Compare the Short Physical Performance Battery frailty score between participants with FEV1 <60% to matched participants with FEV1 ≥60%
timeFrame: Baseline and 1 year
measure: Evaluate mean glucose in participants with FEV1 <60% and matched participants with FEV1 ≥60%
timeFrame: Baseline and 1 year
measure: Evaluate % time above 140 mg/dL in participants with FEV1 <60% and matched participants with FEV1 ≥60%
timeFrame: Baseline and 1 year
measure: Evaluate % time above 180 mg/dL in participants with FEV1 <60% and matched participants with FEV1 ≥60%
timeFrame: Baseline and 1 year
measure: Evaluate peak glucose in participants with FEV1 <60% and matched participants with FEV1 ≥60%
timeFrame: Baseline and 1 year
measure: Evaluate % time below 70 mg/dL in participants with FEV1 <60% and matched participants with FEV1 ≥60%
timeFrame: Baseline and 1 year
measure: Evaluate % time below 54 mg/dL in participants with FEV1 <60% and matched participants with FEV1 ≥60%
timeFrame: Baseline and 1 year
measure: Evaluate the standard deviation in CGM glucose data in participants with FEV1 <60% and matched participants with FEV1 ≥60%
timeFrame: Baseline and 1 year
measure: Evaluate the coefficient of variation in CGM glucose data in participants with FEV1 <60% and matched participants with FEV1 ≥60%participants with FEV1 ≥60%
timeFrame: Baseline and 1 year
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences (UAMS)
state: Arkansas
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Atlanta
country: United States
facility: Emory
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
city: Baltimore
country: United States
facility: John Hopkins University
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital (MGH)
state: Massachusetts
city: Boston
country: United States
facility: Boston Children's Hospital and Brigham and Women's CF Center
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine (St. Louis)
state: Missouri
city: Hawthorne
country: United States
facility: New York Medical College (NYMC)
state: New York
city: New Hyde Park
country: United States
facility: Northwell LIJ Adult Cystic Fibrosis Center
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Sciences Center
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Houston
country: United States
facility: Baylor University
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Cystic Fibrosis Center
state: Virginia
Study officials:
affiliation: Northwestern University
name: Adam Stein
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Jessica Alvarez
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Melissa Putman
role: PRINCIPAL_INVESTIGATOR
References: