Cystic Fibrosis Clinical Trial
— BEAM-CFOfficial title:
Integration of Nutritional Metabolomics With Bioenergetics in Cystic Fibrosis
Verified date | November 2019 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
With better medical care, patients with cystic fibrosis (CF), a life-threatening disease, are enjoying longer lives. As the CF life expectancy increases, conditions such as CF-related diabetes (CFRD) become more prevalent. Nutrition plays a major role in maintaining optimal health in cystic fibrosis (CF). This project is designed to investigate nutrition-related factors, such as diet and body composition, on outcomes in patients with CF. The data generated from this study will be used to inform future nutrition intervention studies in adults with CF and CFRD.
Status | Completed |
Enrollment | 50 |
Est. completion date | November 7, 2018 |
Est. primary completion date | November 7, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility |
Cystic Fibrosis Inclusion Criteria: - have confirmed CF diagnosis with at least one Class I to III CFTR mutations - age = 18 yrs - on a clinically-stable medical regimen for 3 wks - no intravenous or oral antibiotics for at least 3 wks prior to study visit Exclusion Criteria: - current pregnancy - unwilling or unable to discontinue enteral tube feeds for one night before the study visit, if applicable - most recent FEV1% <40% - drug (recreational or prescription) or alcohol abuse - pacemaker or any electronic implantable device - unable to give informed consent Healthy volunteers Inclusion criteria: - 18-50 yrs of age - ambulatory status - absence of hospitalization in the previous year except for accidents Exclusion criteria: - current pregnancy - current active malignant neoplasm or history of malignancy (other than localized basal cell cancer of the skin) during the previous 5 years - current respiratory disease including asthma, chronic obstructive pulmonary disorder, or emphysema - current chronic autoimmune or pro-inflammatory disease - history of tuberculosis, HIV, or other chronic infection - previous diagnosis of type 1 or type 2 diabetes with active treatment with insulin or other glucose lowering medication - advanced (= stage 3) renal disease - body mass index (BMI) = 30 kg/m2 - acute illness (such as a viral infection) within the past 2 weeks - current use of any prescription medications that would indicate presence of an acute or chronic medical condition that may influence study results - drug (recreational or prescription) or alcohol abuse - weight instability (± 10% body weight within the last 6 months) or current participation in weight loss or weight gain program - inability to provide informed consent. |
Country | Name | City | State |
---|---|---|---|
United States | Emory University Hospital | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | whole-body fasting fat oxidation | This will be assessed using indirect calorimetry | Baseline for cross-sectional study and 1 year for longitudinal study | |
Other | 31P-magnetic resonance spectroscopy (MRS)-derived measures of resting thigh skeletal muscle bioenergetic metabolism | This will be assessed using MRI | Baseline for cross-sectional study | |
Primary | Acylcarnitine analysis by high-resolution liquid chromatography mass spectrometry | This will pe performed using targeted metabolomics methods | Baseline for cross-sectional study and 1 year for longitudinal study | |
Secondary | quantitative plasma levels of specific plasma acylcarnitines | This will be measured in fasted blood | Baseline for cross-sectional study and 1 year for longitudinal study |
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