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Examination of the Lipid Metabolism of the Liver After Choline Substitution in Cystic Fibrosis

Primary Purpose

Cystic Fibrosis Liver Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Choline Chloride
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis Liver Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Age > 18 years
  • male
  • Cystic fibrosis is verified
  • pancreatic insufficiency
  • Decline of plasma phosphatidylcholine and steatosis of the liver
  • informed consent is given

Exclusion Criteria:

  • cirrhosis of the liver
  • Hyperreactivity to choline containing food
  • allergic bronchopulmonary aspergillosis or other acute exacerbations of pulmonary infections
  • FEV1 < 40%
  • smoker
  • chronic alcohol consume
  • clinically relevant diseases (for example thyroid dysfunction, disturbance of lipid metabolism, renal diseases, significant left or right ventricular functional restriction) which will change the lipid metabolism of the liver
  • Implants or other reasons which make magnetic resonance examinations impossible

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Choline Chloride

    Arm Description

    Patients receive choline chloride (1g Choline) three times a day for 12.6 weeks as a food supply

    Outcomes

    Primary Outcome Measures

    Measurement of D9-Methyl-Choline Kinetic
    The substitution of choline as a food supplement will augment the phosphatidylcholine and lipoprotein (VLDL) secretion of the liver into the blood and will therefore result in a reduction of the triglyceride retention in the liver

    Secondary Outcome Measures

    Lipid storage of the liver
    Comparison of steatosis of the liver (measured by magnetic resonance spectroscopy or sonography) before to after the choline substitution
    Augmentation of creatinine concentration within the calf muscle
    Augmentation of creatine concentration within the calf muscle due to the choline substitution measured by magnetic resonance spectroscopy
    FVC
    Comparison of FVC before to after the choline substitution
    FEV1
    Comparison of FEV1 before to after the choline substitution
    MEF25
    Comparison of MEF25 before to after the choline substitution
    MMEF
    Comparison of MMEF before to after the choline substitution

    Full Information

    First Posted
    October 4, 2017
    Last Updated
    November 29, 2017
    Sponsor
    University Hospital Tuebingen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03312140
    Brief Title
    Examination of the Lipid Metabolism of the Liver After Choline Substitution in Cystic Fibrosis
    Official Title
    Examination of the Lipid Metabolism of the Liver After Choline Substitution in Cystic Fibrosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 6, 2014 (Actual)
    Primary Completion Date
    April 24, 2016 (Actual)
    Study Completion Date
    February 8, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital Tuebingen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Pilot study to investigate the effect of choline chloride in cystic fibrosis patients with liver steatosis by comparing their status before and after the intervention
    Detailed Description
    Within this single arm pilot study patients with cystic fibrosis and liver steatosis receive choline chloride (2x0.5 gram three times a day) as a food supply for 88 days. D9-choline metabolism is measured before and after the intervention phase. Hypothesis of the study is, that supplying choline augments the secretion of phosphatidyl choline and lipoprotein (VLDL) from the liver and therefore results in a measurable reduction of the triglyceride storage of the liver.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cystic Fibrosis Liver Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Pilot study to evolve the effect ot the treatment by comparing data before and after the treatment within the same patients
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Choline Chloride
    Arm Type
    Other
    Arm Description
    Patients receive choline chloride (1g Choline) three times a day for 12.6 weeks as a food supply
    Intervention Type
    Drug
    Intervention Name(s)
    Choline Chloride
    Primary Outcome Measure Information:
    Title
    Measurement of D9-Methyl-Choline Kinetic
    Description
    The substitution of choline as a food supplement will augment the phosphatidylcholine and lipoprotein (VLDL) secretion of the liver into the blood and will therefore result in a reduction of the triglyceride retention in the liver
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Lipid storage of the liver
    Description
    Comparison of steatosis of the liver (measured by magnetic resonance spectroscopy or sonography) before to after the choline substitution
    Time Frame
    3 months
    Title
    Augmentation of creatinine concentration within the calf muscle
    Description
    Augmentation of creatine concentration within the calf muscle due to the choline substitution measured by magnetic resonance spectroscopy
    Time Frame
    3 months
    Title
    FVC
    Description
    Comparison of FVC before to after the choline substitution
    Time Frame
    3 months
    Title
    FEV1
    Description
    Comparison of FEV1 before to after the choline substitution
    Time Frame
    3 months
    Title
    MEF25
    Description
    Comparison of MEF25 before to after the choline substitution
    Time Frame
    3 months
    Title
    MMEF
    Description
    Comparison of MMEF before to after the choline substitution
    Time Frame
    3 months

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age > 18 years male Cystic fibrosis is verified pancreatic insufficiency Decline of plasma phosphatidylcholine and steatosis of the liver informed consent is given Exclusion Criteria: cirrhosis of the liver Hyperreactivity to choline containing food allergic bronchopulmonary aspergillosis or other acute exacerbations of pulmonary infections FEV1 < 40% smoker chronic alcohol consume clinically relevant diseases (for example thyroid dysfunction, disturbance of lipid metabolism, renal diseases, significant left or right ventricular functional restriction) which will change the lipid metabolism of the liver Implants or other reasons which make magnetic resonance examinations impossible
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Joachim Riethmüller, PD
    Organizational Affiliation
    Klinik für Kinder- und Jugendmedizin Tübingen
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Examination of the Lipid Metabolism of the Liver After Choline Substitution in Cystic Fibrosis

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