BioEnergetics and Metabolomics in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

— BEAM-CF  

Official title:

Integration of Nutritional Metabolomics With Bioenergetics in Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02225899
• Other study ID #: IRB00073559
• Secondary ID: K01DK102851
• Status: Completed
• Start date: September 2014
• Est. completion date: November 7, 2018

Study information

• Verified date: November 2019
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

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