Role of Body Fat Distribution in Metabolic and Pulmonary Decline in Cystic Fibrosis (ORBIT-CF)
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|ClinicalTrials.gov Identifier: NCT04002882|
Recruitment Status : Recruiting
First Posted : July 1, 2019
Last Update Posted : August 2, 2019
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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||90 participants|
|Official Title:||Outcomes Related to Body Composition in Teens and Adults With Cystic Fibrosis (ORBIT-CF)|
|Actual Study Start Date :||July 8, 2019|
|Estimated Primary Completion Date :||April 1, 2022|
|Estimated Study Completion Date :||April 1, 2022|
Subjects with Cystic Fibrosis
n=60 patients with CF ages 16-30
n=30 healthy controls matched to participants with CF for age, sex, BMI, and race.
- Change in Visceral Adipose Tissue volume (VAT) by Magnetic Resonance Imaging (MRI) [ Time Frame: Baseline, 1 year, 2 year ]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)
- Change in Disposition Index [ Time Frame: Baseline, 1 year, 2 year ]
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.
- Change in Forced Expiratory Volume in the first second (FEV1%) [ Time Frame: Baseline, 1 year, 2 year ]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.
- Change in Pancreatic lipid [ Time Frame: Baseline, 1 year, 2 year ]
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
- Change in Hepatic lipid [ Time Frame: Baseline, 1 year, 2 year ]
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
- Change in Thigh perimuscular adipose tissue (PMAT) [ Time Frame: Baseline, 1 year, 2 year ]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
- Change in Body Composition Analysis [ Time Frame: Baseline, 1 year, 2 year ]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.
- Change in Insulin secretion [ Time Frame: Baseline, 1 year, 2 year ]
Insulin secretion measures the total beta cell response (PhiTot), and will be assessed with an oral glucose tolerance test (OGTT).
Fasted blood samples will be drawn 30 minutes and 15 minutes before the initiation of glucose consumption. At time "zero", an oral glucose solution at the dose of 1.75 gm/kg to a maximum of 75 gms will be provided and consumed within 5 minutes of administration. Subsequent blood samples will be drawn at 10, 20, 30, 60, 90, and 120 min following initiation of glucose ingestion.
Decreased insulin secretion has been associated with lower B-cell function.
- Change in Whole body insulin sensitivity index (WBISI) [ Time Frame: Baseline, 1 year, 2 year ]
Insulin sensitivity describes how sensitive the body is to the effects of insulin. Whole body insulin sensitivity index (WBISI) is derived from glucose and insulin levels from the full length of the OGTT. The index is calculated using a formula.
Decreased insulin sensitivity index is associated with more advanced CF disease.
- Annual rate of Forced Expiratory Volume in the first second (FEV1%) decline [ Time Frame: Baseline, 1 year, 2 year ]
FEV1 is the maximal amount of air you can forcefully exhale in one second. It is then converted to a percentage of normal, based on your height, weight, and race.
It is assessed when doing the spirometry.
- Number of pulmonary exacerbations needing intravenous (IV) antibiotics within previous five years [ Time Frame: Baseline ]
- Number of Perceived respiratory symptoms measured with the Cystic Fibrosis Questionnaire-Revised (CFQ-R) [ Time Frame: Baseline, 1 year, 2 year ]
The Cystic Fibrosis Questionnaire-Revised (CFQ-R) is a disease-specific instrument, designed to measure impact on overall health, daily life, perceived well-being and symptoms.
Scores range from 0 to 100, with higher scores indicating better health.
Biospecimen Retention: Samples Without DNA
Specimens that remain after completion of the study will be stored for future studies beyond the scope of the current study only if subjects denote the appropriate section of the informed consent form to grant long term storage of samples. Specimens and data will be stored at Emory University within the PI's (Jessica Alvarez) laboratory. Any stored samples will be de-identified with a specific code whose identity can only be accessed by authorized study personnel appointed by the PI.
During the conduct of the study, an individual participant can choose to withdraw consent to have biological specimens stored for future research. However, withdrawal of consent with regard to bio-sample storage may not be possible after the study is completed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04002882
|Contact: Elizabeth Ivie, RDfirstname.lastname@example.org|
|Contact: Jessica A Alvarez, PhD, RDemail@example.com|
|United States, Alabama|
|University of Alabama at Birmingham (UAB)/Children's of Alabama||Not yet recruiting|
|Birmingham, Alabama, United States, 35233|
|Contact: Michael Stalvey, MD 205-638-9107|
|United States, Georgia|
|Emory University/Children's Hospital of Atlanta (CHOA)||Recruiting|
|Atlanta, Georgia, United States, 30322|
|Contact: Jessica Alvarez, PhD, RD 404-727-1390 firstname.lastname@example.org|
|Principal Investigator:||Jessica A Alvarez, PhD, RD||Emory University|