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Completed

NCT Number: NCT03312140

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

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

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Key information

Conditions

Cystic Fibrosis Liver Disease

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

choline chloride

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Oct 17, 2017
Registry last updated
Nov 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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