Clinical trial NCT02225899: BioEnergetics and Metabolomics in Cystic Fibrosis
Official title: Integration of Nutritional Metabolomics With Bioenergetics in Cystic Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2014-08-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with cystic fibrosis and healthy volunteers from the Atlanta community

Brief summary: 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.

Detailed description: Research methods include blood draws for plasma markers of oxidative stress and metabolomics (the measurement of thousands of small chemicals in the blood), magnetic resonance imaging (MRI, to assess energy capacity and thigh fat), dual energy X-ray absorptiometry (DEXA, to assess total and regional body fat and muscle), and indirect calorimetry (to assess resting energy expenditure and whole body fat oxidation). Clinically-relevant data, such as lung function, CF genotype, and diabetes status will be obtained from the electronic medical record and the CF Registry.

Eligibility criteria: 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.

Primary outcomes:
measure: Acylcarnitine analysis by high-resolution liquid chromatography mass spectrometry
timeFrame: Baseline for cross-sectional study and 1 year for longitudinal study
Secondary outcomes:
measure: quantitative plasma levels of specific plasma acylcarnitines
timeFrame: Baseline for cross-sectional study and 1 year for longitudinal study
Other outcomes:
measure: whole-body fasting fat oxidation
timeFrame: Baseline for cross-sectional study and 1 year for longitudinal study
measure: 31P-magnetic resonance spectroscopy (MRS)-derived measures of resting thigh skeletal muscle bioenergetic metabolism
timeFrame: Baseline for cross-sectional study
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Jessica A Alvarez, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References: