BioEnergetics and Metabolomics in Cystic Fibrosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2018-11-07

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cystic Fibrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects with Cystic Fibrosis

Cross-sectional, observational study

No interventions assigned to this group

healthy volunteers

Cross-sectional, observational study

No interventions assigned to this group

Subjects with CF in a vitamin D study

This is a longitudinal observational study in subjects enrolled in a high-dose vitamin D study. The investigator (Jessica Alvarez) does not assign the intervention to the subjects of the study.

No interventions assigned to this group

Eligibility Criteria

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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

* 18-50 yrs of age
* ambulatory status
* absence of hospitalization in the previous year except for accidents

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

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes