Status:
COMPLETED
BioEnergetics and Metabolomics in Cystic Fibrosis
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
18-50 years
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) ...
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 ...
Eligibility Criteria
Inclusion
- Cystic Fibrosis
- 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
- 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.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 7 2018
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02225899
Start Date
September 1 2014
End Date
November 7 2018
Last Update
November 29 2019
Active Locations (1)
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1
Emory University Hospital
Atlanta, Georgia, United States, 30322