Role of Body Fat Distribution in Metabolic and Pulmonary Decline in Cystic Fibrosis (ORBIT-CF)
ConditionCystic Fibrosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorEmory University
About this trial
Nutrition and body composition, the amount of muscle and fat in the body, has a role in overall health. This study wants to learn more about how nutrition and body composition affects health outcomes like glucose tolerance and lung function in patients with cystic fibrosis (CF) who are ages 16-30 years old. 60 adolescents and young adults with CF will be recruited, and 30 volunteers without cystic fibrosis. A total of 40 of these study participants with CF will be asked to return for annual study visits for 2 years after the first visit.
The long-term goal of this study is to use the information collected to make decisions about future nutrition monitoring and interventions which help maintain optimal health for individuals with CF.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
confirmed CF diagnosis based on sweat testing by pilocarpine iontophoresis and/or CFTR genotyping with two disease causing mutations
be aged ≥ 16 yrs
clinically stable, defined as no changes in medical regimen (including medications) for at least 21 days prior to study visit
participation in the CFF Patient Registry
Disqualifiers
diagnosis of CF-related diabetes (CFRD)
nocturnal tube feeds
life expectancy <6 months
history of or on waiting list for lung transplant
Trial population
This will be a two-site study of n=60 patients with CF ages 16 years and older and n=30 age-, sex-, BMI-, and race-matched healthy controls. As a sub-study, 40 of these CF subjects will be followed longitudinally and assessed annually for two years.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
90 Participants
are grouped into 2 trial groupsGroup A: Subjects with Cystic Fibrosis
Group B: Healthy Controls
Trial outcomes
Primary outcomes
1
Change in Visceral Adipose Tissue volume (VAT) by Magnetic Resonance Imaging (MRI)
Body fat distribution and body composition in 60 individuals with Cystic Fibrosis (CF) and 30 matched, healthy control will be assessed by Magnetic Resonance Imaging (MRI)
Time frame
Baseline, 1 year, 2 year2
Change in Disposition Index
The disposition index (DI) is a measure of the ability of B-cells to compensate for insulin resistance. A lower DI indicates a loss of B-cell function, which means decreased pancreatic function. The disposition index will be assessed with an oral glucose tolerance test (OGTT) and mathematical modeling of the C-peptide and insulin response to glucose. This study seeks to determine if glucose intolerance is associated with body composition and fat distribution in CF subjects.
Time frame
Baseline, 1 year, 2 year3
Change in Forced Expiratory Volume in the first second (FEV1%)
Clinical spirometry is a test of lung function that will be used to assess the progression of lung disease with the baseline Forced Expiratory Volume (FEV%) predicted within the past year. Baseline is defined as the average of the best FEV1% for each quarter of the calendar year. FEV1% predicted is a method of determining the severity of pulmonary disease and declines as disease severity increases.
Time frame
Baseline, 1 year, 2 yearSecondary outcomes
1
Change in Pancreatic lipid
Pancreatic lipid contributes to the Visceral Adipose Tissue volume (VAT) and it will me measured with the magnetic resonance imaging (MRI). Participants will lay in the supine position for approximately 30 minutes while in the MRI scanner, and images of the abdominal area (L1-L5 vertebrae) and thigh area will be obtained. Images will later be analyzed for quantification of VAT volume and lipid content of pancreas will be analyzed
Time frame
Baseline, 1 year, 2 year2
Change in Hepatic lipid
Hepatic lipid contributes to the Visceral Adipose Tissue volume (VAT) and it will me measured with the MRI. Participants will lay in the supine position for approximately 30 minutes while in the MRI scanner, and images of the abdominal area (L1-L5 vertebrae) and thigh area will be obtained. Images will later be analyzed for quantification of VAT volume and lipid content of liver will be analyzed
Time frame
Baseline, 1 year, 2 year3
Change in Thigh perimuscular adipose tissue (PMAT)
Thigh PMAT contributes to the VAT and it will me measured with the MRI. Participants will lay in the supine position for approximately 30 minutes while in the MRI scanner, and images of the abdominal area (L1-L5 vertebrae) and thigh area will be obtained. Images will later be analyzed for quantification of VAT volume and Thigh PMAT
Time frame
Baseline, 1 year, 2 year4
Change in Body Composition Analysis
Dual-energy X-ray absorptiometry (DEXA) is an imaging technique that provides whole body and regional estimates of the three main body components: fat, lean soft tissues and bone mineral mass.
Time frame
Baseline, 1 year, 2 yearSponsors and contacts
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Emory University
Lead sponsor
Cystic Fibrosis Foundation
Collaborator
Source ClinicalTrials.gov