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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Cystic Fibrosis
Intervention / Treatment

-

Contacts and Locations

Tucson

University of Arizona, Tucson, Arizona, United States, 85724

Little Rock

University of Arkansas for Medical Sciences (UAMS), Little Rock, Arkansas, United States, 72205

New Haven

Yale University School of Medicine, New Haven, Connecticut, United States, 06520

Atlanta

Emory, Atlanta, Georgia, United States, 30324

Chicago

Northwestern University, Chicago, Illinois, United States, 60611

Iowa City

University of Iowa, Iowa City, Iowa, United States, 52242

Lexington

University of Kentucky, Lexington, Kentucky, United States, 40508

New Orleans

Tulane University, New Orleans, Louisiana, United States, 70112

Baltimore

John Hopkins University, Baltimore, Maryland, United States, 21287

Boston

Massachusetts General Hospital (MGH), Boston, Massachusetts, United States, 02114

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Jaeb Center for Health Research,

Adam Stein, PRINCIPAL_INVESTIGATOR, Northwestern

Jessica Alvarez, PRINCIPAL_INVESTIGATOR, Emory University

Melissa Putman, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

2028-12