<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02225899</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00073559</org_study_id>
    <secondary_id>K01DK102851</secondary_id>
    <nct_id>NCT02225899</nct_id>
  </id_info>
  <brief_title>BioEnergetics and Metabolomics in Cystic Fibrosis</brief_title>
  <acronym>BEAM-CF</acronym>
  <official_title>Integration of Nutritional Metabolomics With Bioenergetics in Cystic Fibrosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Emory University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      With better medical care, patients with cystic fibrosis (CF), a life-threatening disease, are&#xD;
      enjoying longer lives. As the CF life expectancy increases, conditions such as CF-related&#xD;
      diabetes (CFRD) become more prevalent. Nutrition plays a major role in maintaining optimal&#xD;
      health in cystic fibrosis (CF). This project is designed to investigate nutrition-related&#xD;
      factors, such as diet and body composition, on outcomes in patients with CF. The data&#xD;
      generated from this study will be used to inform future nutrition intervention studies in&#xD;
      adults with CF and CFRD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Research methods include blood draws for plasma markers of oxidative stress and metabolomics&#xD;
      (the measurement of thousands of small chemicals in the blood), magnetic resonance imaging&#xD;
      (MRI, to assess energy capacity and thigh fat), dual energy X-ray absorptiometry (DEXA, to&#xD;
      assess total and regional body fat and muscle), and indirect calorimetry (to assess resting&#xD;
      energy expenditure and whole body fat oxidation). Clinically-relevant data, such as lung&#xD;
      function, CF genotype, and diabetes status will be obtained from the electronic medical&#xD;
      record and the CF Registry.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">November 7, 2018</completion_date>
  <primary_completion_date type="Actual">November 7, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Acylcarnitine analysis by high-resolution liquid chromatography mass spectrometry</measure>
    <time_frame>Baseline for cross-sectional study and 1 year for longitudinal study</time_frame>
    <description>This will pe performed using targeted metabolomics methods</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>quantitative plasma levels of specific plasma acylcarnitines</measure>
    <time_frame>Baseline for cross-sectional study and 1 year for longitudinal study</time_frame>
    <description>This will be measured in fasted blood</description>
  </secondary_outcome>
  <other_outcome>
    <measure>whole-body fasting fat oxidation</measure>
    <time_frame>Baseline for cross-sectional study and 1 year for longitudinal study</time_frame>
    <description>This will be assessed using indirect calorimetry</description>
  </other_outcome>
  <other_outcome>
    <measure>31P-magnetic resonance spectroscopy (MRS)-derived measures of resting thigh skeletal muscle bioenergetic metabolism</measure>
    <time_frame>Baseline for cross-sectional study</time_frame>
    <description>This will be assessed using MRI</description>
  </other_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Cystic Fibrosis</condition>
  <arm_group>
    <arm_group_label>Subjects with Cystic Fibrosis</arm_group_label>
    <description>Cross-sectional, observational study</description>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy volunteers</arm_group_label>
    <description>Cross-sectional, observational study</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subjects with CF in a vitamin D study</arm_group_label>
    <description>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.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      We will collect sputum, urine, and blood.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Adults with cystic fibrosis and healthy volunteers from the Atlanta community&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Cystic Fibrosis&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  have confirmed CF diagnosis with at least one Class I to III CFTR mutations&#xD;
&#xD;
          -  age ≥ 18 yrs&#xD;
&#xD;
          -  on a clinically-stable medical regimen for 3 wks&#xD;
&#xD;
          -  no intravenous or oral antibiotics for at least 3 wks prior to study visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  current pregnancy&#xD;
&#xD;
          -  unwilling or unable to discontinue enteral tube feeds for one night before the study&#xD;
             visit, if applicable&#xD;
&#xD;
          -  most recent FEV1% &lt;40%&#xD;
&#xD;
          -  drug (recreational or prescription) or alcohol abuse&#xD;
&#xD;
          -  pacemaker or any electronic implantable device&#xD;
&#xD;
          -  unable to give informed consent&#xD;
&#xD;
        Healthy volunteers&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
          -  18-50 yrs of age&#xD;
&#xD;
          -  ambulatory status&#xD;
&#xD;
          -  absence of hospitalization in the previous year except for accidents&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  current pregnancy&#xD;
&#xD;
          -  current active malignant neoplasm or history of malignancy (other than localized basal&#xD;
             cell cancer of the skin) during the previous 5 years&#xD;
&#xD;
          -  current respiratory disease including asthma, chronic obstructive pulmonary disorder,&#xD;
             or emphysema&#xD;
&#xD;
          -  current chronic autoimmune or pro-inflammatory disease&#xD;
&#xD;
          -  history of tuberculosis, HIV, or other chronic infection&#xD;
&#xD;
          -  previous diagnosis of type 1 or type 2 diabetes with active treatment with insulin or&#xD;
             other glucose lowering medication&#xD;
&#xD;
          -  advanced (≥ stage 3) renal disease&#xD;
&#xD;
          -  body mass index (BMI) ≥ 30 kg/m2&#xD;
&#xD;
          -  acute illness (such as a viral infection) within the past 2 weeks&#xD;
&#xD;
          -  current use of any prescription medications that would indicate presence of an acute&#xD;
             or chronic medical condition that may influence study results&#xD;
&#xD;
          -  drug (recreational or prescription) or alcohol abuse&#xD;
&#xD;
          -  weight instability (± 10% body weight within the last 6 months) or current&#xD;
             participation in weight loss or weight gain program&#xD;
&#xD;
          -  inability to provide informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jessica A Alvarez, PhD, RD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emory University Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 26, 2014</study_first_posted>
  <last_update_submitted>November 27, 2019</last_update_submitted>
  <last_update_submitted_qc>November 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Jessica Alvarez</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystic Fibrosis</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02225899
org study id: IRB00073559
secondary id: K01DK102851
nct id: NCT02225899
lead sponsor: 
collaborator: 
has dmc: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Acylcarnitine analysis by high-resolution liquid chromatography mass spectrometry
time frame: Baseline for cross-sectional study and 1 year for longitudinal study
description: This will pe performed using targeted metabolomics methods
measure: quantitative plasma levels of specific plasma acylcarnitines
time frame: Baseline for cross-sectional study and 1 year for longitudinal study
description: This will be measured in fasted blood
measure: whole-body fasting fat oxidation
time frame: Baseline for cross-sectional study and 1 year for longitudinal study
description: This will be assessed using indirect calorimetry
measure: 31P-magnetic resonance spectroscopy (MRS)-derived measures of resting thigh skeletal muscle bioenergetic metabolism
time frame: Baseline for cross-sectional study
description: This will be assessed using MRI
arm group label: Subjects with Cystic Fibrosis
description: Cross-sectional, observational study
arm group label: healthy volunteers
description: Cross-sectional, observational study
arm group label: Subjects with CF in a vitamin D study
description: 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.
We will collect sputum, urine, and blood.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jessica A Alvarez, PhD, RD
role: Principal Investigator
affiliation: Emory University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Jessica Alvarez
investigator title: Assistant Professor
mesh term: Cystic Fibrosis
mesh term: Fibrosis