Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

BioEnergetics and Metabolomics in Cystic Fibrosis (BEAM-CF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02225899
Recruitment Status : Recruiting
First Posted : August 26, 2014
Last Update Posted : July 3, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Jessica Alvarez, Emory University

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.

Condition or disease
Cystic Fibrosis

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Integration of Nutritional Metabolomics With Bioenergetics in Cystic Fibrosis
Study Start Date : September 2014
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Group/Cohort
Subjects with Cystic Fibrosis
Cross-sectional, observational study
healthy volunteers
Cross-sectional, observational study
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.



Primary Outcome Measures :
  1. Acylcarnitine analysis by high-resolution liquid chromatography mass spectrometry [ Time Frame: Baseline for cross-sectional study and 1 year for longitudinal study ]
    This will pe performed using targeted metabolomics methods


Secondary Outcome Measures :
  1. quantitative plasma levels of specific plasma acylcarnitines [ Time Frame: Baseline for cross-sectional study and 1 year for longitudinal study ]
    This will be measured in fasted blood


Other Outcome Measures:
  1. whole-body fasting fat oxidation [ Time Frame: Baseline for cross-sectional study and 1 year for longitudinal study ]
    This will be assessed using indirect calorimetry

  2. 31P-magnetic resonance spectroscopy (MRS)-derived measures of resting thigh skeletal muscle bioenergetic metabolism [ Time Frame: Baseline for cross-sectional study ]
    This will be assessed using MRI


Biospecimen Retention:   Samples Without DNA
We will collect sputum, urine, and blood.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adults with cystic fibrosis and healthy volunteers from the Atlanta community
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02225899


Contacts
Layout table for location contacts
Contact: Elizabeth A Ivie, RD (404) 727-1399 elizabeth.a.ivie@emory.edu
Contact: Jessica A Alvarez, PhD, RD 404-727-1390 jessica.alvarez@emory.edu

Locations
Layout table for location information
United States, Georgia
Emory university Hospital Recruiting
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Layout table for investigator information
Principal Investigator: Jessica A Alvarez, PhD, RD Emory University

Layout table for additonal information
Responsible Party: Jessica Alvarez, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT02225899     History of Changes
Other Study ID Numbers: IRB00073559
K01DK102851 ( U.S. NIH Grant/Contract )
First Posted: August 26, 2014    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
Layout table for MeSH terms
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases