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Diagnostic Test

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

N/A

Recruiting

Led By Melissa Putman

Research Sponsored by Jaeb Center for Health Research

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 1 year

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Cystic Fibrosis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Correlation between DXA lean mass index and BMI

Correlation between DXA lean mass index and Short Physical Performance Battery frailty score

Correlation between DXA lean mass index and hand-grip strength

+3 more

Secondary study objectives

Characterize 1 minute sit-to-stand repetitions cross-sectionally and longitudinally

Characterize BMI cross-sectionally and longitudinally

Characterize hand-grip strength cross-sectionally and longitudinally

+19 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 2Experimental Treatment24 Interventions

FEV1 ≥60% predicted during the 12 months prior to enrollment (\>50% of measurements, eliminating periods of exacerbation).

Group II: Cohort 1Experimental Treatment24 Interventions

Forced expiratory volume in 1 second (FEV1) \<60% 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Continuous glucose monitoring (CGM)

2016

Completed Phase 4

~230

Spirometry

2017

Completed Phase 2

~12540