A Pathophysiological Study of the Postprandial Human Liver (PLS)

NCT ID: NCT03849235

Last Updated: 2021-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-02

Study Completion Date

2025-01-01

Brief Summary

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Fatty liver disease is a globally widespread disease The identification of valid biomarkers and targets for potential treatments requires in-depth knowledge about the pathophysiology of the postprandial liver. The study will consist of five work packages (WP) including blood tests and liver biopsies taken after fasting or ingestion of a standardized meal in: healthy controls (WP 1), patients with NAFLD (WP 2), and patients with cirrhosis (WP 3) ; before and after a standardised meal in healthy controls (WP 4), and before and after glucagon in healthy controls (WP5)

Detailed Description

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Conditions

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Cirrhosis Fatty Liver

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Standardised meal or glucagon

Standardised meal (Nutridrink, Nutricia, 300 kcal, 18.4 g carbohydrates, 5.8 g fat, 12 g protein) or 1mg glucagon

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

Cirrhosis (WP 3)

Exclusion Criteria

NAFLD ( WP 2)
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Copenhagen

OTHER

Sponsor Role collaborator

Copenhagen University Hospital, Hvidovre

OTHER

Sponsor Role lead

Responsible Party

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Lise Gluud

Consultant hepatologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicolai Jacob Wewer Albrechtsen, MD, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

NNF Center for Protein Research, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark

Lise Lotte Gluud, MD, Prof

Role: PRINCIPAL_INVESTIGATOR

Gastrounit, Copenhagen University Hospital Hvidovre, Denmark

Locations

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Gastrounit, Copenhagen University Hospital Hvidovre

Hvidovre, Capital Region Denmark, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Juliana JV Grandt, MD

Role: CONTACT

+45 38623862

Facility Contacts

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Lise L Gluud, MD

Role: primary

+4538621964

Related Links

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Other Identifiers

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H-18052725

Identifier Type: -

Identifier Source: org_study_id

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