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

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ClinicalTrials.gov Identifier: NCT03312140
Recruitment Status : Completed
First Posted : October 17, 2017
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital Tuebingen

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

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Liver Disease Drug: Choline Chloride Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Examination of the Lipid Metabolism of the Liver After Choline Substitution in Cystic Fibrosis
Actual Study Start Date : November 6, 2014
Actual Primary Completion Date : April 24, 2016
Actual Study Completion Date : February 8, 2017


Arm Intervention/treatment
Choline Chloride
Patients receive choline chloride (1g Choline) three times a day for 12.6 weeks as a food supply
Drug: Choline Chloride



Primary Outcome Measures :
  1. Measurement of D9-Methyl-Choline Kinetic [ Time Frame: 3 months ]
    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 :
  1. Lipid storage of the liver [ Time Frame: 3 months ]
    Comparison of steatosis of the liver (measured by magnetic resonance spectroscopy or sonography) before to after the choline substitution

  2. Augmentation of creatinine concentration within the calf muscle [ Time Frame: 3 months ]
    Augmentation of creatine concentration within the calf muscle due to the choline substitution measured by magnetic resonance spectroscopy

  3. FVC [ Time Frame: 3 months ]
    Comparison of FVC before to after the choline substitution

  4. FEV1 [ Time Frame: 3 months ]
    Comparison of FEV1 before to after the choline substitution

  5. MEF25 [ Time Frame: 3 months ]
    Comparison of MEF25 before to after the choline substitution

  6. MMEF [ Time Frame: 3 months ]
    Comparison of MMEF before to after the choline substitution



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

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): NCT03312140


Sponsors and Collaborators
University Hospital Tuebingen
Investigators
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Principal Investigator: Joachim Riethmüller, PD Klinik für Kinder- und Jugendmedizin Tübingen

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Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT03312140     History of Changes
Other Study ID Numbers: Phos-CF II V1.2
First Posted: October 17, 2017    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cystic Fibrosis
Liver Diseases
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Choline
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents