Role of Body Fat Distribution in Metabolic and Pulmonary Decline in Cystic Fibrosis (ORBIT-CF)

  • STATUS
    Recruiting
  • days left to enroll
    56
  • participants needed
    90
  • sponsor
    Emory University
Updated on 4 October 2022
pulmonary function test
fibrosis
pilocarpine
pancreatic insufficiency
sweat test
Accepts healthy volunteers

Summary

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.

Description

This is a prospective, observation study to test the central hypothesis that individuals with cystic fibrosis (CF) have a higher propensity to increased visceral adipose tissue (VAT) accumulation and decreased lean body mass (LBM) compared to healthy controls, and this dysregulation in adipose and protein deposition exacerbates glucose intolerance and lung function decline. A sub-set of participants with CF will be followed longitudinally for two years (n=40). The investigators will conduct detailed body composition, fat distribution, metabolic, and nutritional phenotyping in this cohort. Body fat distribution will be assessed with MRI. Whole body composition will be assessed with DEXA. Glucose tolerance will be assessed with an oral glucose tolerance test (OGTT) and mathematical modeling of the C-peptide and insulin response to glucose. Lung health will be assessed by objective clinical data and self-reported symptoms.

Details
Condition Cystic Fibrosis
Clinical Study IdentifierNCT04002882
SponsorEmory University
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

CF inclusion criteria
confirmed CF diagnosis based on sweat testing by pilocarpine iontophoresis and/or cystic fibrosis trans membrane genotyping (CFTR) with two disease causing mutations
pancreatic exocrine insufficiency
ages 16 years and older
clinically stable, defined as no changes in medical regimen (including medications) for at least 21 days prior to study visit
baseline FEV1% predicted ≥40% where baseline is defined as the average of the best FEV1% for each quarter of the calendar year
participation in the Cystic Fibrosis Foundation (CFF) Patient Registry
Longitudinal study inclusion
CF participants who have normal glucose tolerance results after their initial study oral
glucose tolerance test (OGTT)
Healthy controls inclusion criteria
male or female ages 16 years and older
clinically stable. Healthy controls will be recruited who are similar in age, gender
and BMI as the participants with CF

Exclusion Criteria

CF exclusion criteria
diagnosis of CF-related diabetes (CFRD)
nocturnal tube feeds
life expectancy <6 months
history of or on waiting list for lung transplant
un-removable metal that is incompatible with MRI
current pregnancy or lactation
inability or unwillingness to perform major study activities (OGTT, DEXA, MRI) due to
claustrophobia, fear of blood draw, or other reasons
inability to provide informed consent or assent
Healthy controls exclusion criteria
HIV or other chronic infection
malignant neoplasm (other than localized basal cell cancer of the skin) during the
current use of any medications to treat an acute or chronic disease or illness
previous 5 years
acute illness within the past 3 weeks
respiratory (including asthma), endocrine (including diabetes), autoimmune, or other
chronic disease
current pregnancy or lactation
inability to provide informed consent or assent
intravenous or oral antibiotics or use of systemic corticosteroids within the past 3
weeks
inability or unwillingness to perform major study activities due to claustrophobia
fear of blood draw, or other reasons
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