The Effect of Induced Hyperammonaemia on Sleep and Melanopsin-mediated Pupillary Light Response in Patients With Liver Cirrhosis

March 14, 2021 updated by: Peter Nissen Bjerring, Rigshospitalet, Denmark
Sleep disturbances are common among patients with liver cirrhosis, but the reasons are not well understood. In this project the investigators evaluated whether an increase in blood ammonia in patients with cirrhosis had an impact on sleep quality and the function of retinal ganglion cells measured by pupillary response to blue light.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Department of gastroenterology and hepatology, Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with a clinical diagnosis of Child Pugh Class A or B cirrhosis
  • Written informed consent
  • >20 and <80 years of age

Exclusion Criteria:

  • Misuse of alcohol in the preceding 6 months,
  • Episodes of hepatic decompensation leading to in-patient admissions during the previous month
  • History or clinical signs of overt HE or severe sleep-wake disturbances
  • On anti-HE treatment (lactulose, rifaximin, Hepa-Merz, Generaid, Bramino)
  • History of significant head injury
  • Neurological/psychiatric comorbidity needing medical treatment
  • Taking neuroactive medication/medication known to affect sleep
  • Travel across more than two time zones in the preceding 3 months
  • Shift work in the preceding 5 years
  • Contraindications for arterial puncture (negative collateral circulation test, wrist infection or vascular abnormalities).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Allocated to intervention at first experimental day
Dietary supplement: Amino Acid Challenge (AAC)
The AAC contains 54 g banana flavoured amino acid mixture added 200-300 mL of water. The AAC simulates the composition of haemoglobin in approximately 400 mL of blood.
Placebo Comparator: Allocated to intervention at second experimental day
Dietary supplement: Amino Acid Challenge (AAC)
The AAC contains 54 g banana flavoured amino acid mixture added 200-300 mL of water. The AAC simulates the composition of haemoglobin in approximately 400 mL of blood.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference in the late post-illumination pupillary response after intervention compared to placebo
Time Frame: 12 days
12 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

January 9, 2018

Study Completion (Actual)

January 22, 2018

Study Registration Dates

First Submitted

February 22, 2021

First Submitted That Met QC Criteria

February 22, 2021

First Posted (Actual)

February 25, 2021

Study Record Updates

Last Update Posted (Actual)

March 16, 2021

Last Update Submitted That Met QC Criteria

March 14, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H15000210

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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