A Pathophysiological Study of the Postprandial Human Liver (PLS)

Cirrhosis Clinical Trial

— PLS  

Official title:

A Pathophysiological Study of the Postprandial Human Liver (PLS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03849235
• Other study ID #: H-18052725
• Status: Recruiting
• Start date: March 2, 2019
• Est. completion date: January 1, 2025

Study information

• Verified date: January 2021
• Source: Copenhagen University Hospital, Hvidovre
• Contact: Juliana JV Grandt, MD
• Phone: +45 38623862
• Email: Juliana.josephine.vivian.grandt[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Healthy participants (WP 1 , WP 4 , WP 5 )

Inclusion criteria: Healthy adults, 20 - 40 years old, non-smoker, BMI 20-25 kg/m2 , no chronical illnesses, no medication.

Exclusion criteria: Blood donation within the past 3 months, acute illness within 2 weeks

NAFLD ( WP 2)

Inclusion criteria: Patients with clinical diagnosis of NAFL and indication for liver biopsy Exclusion criteria: Malignant disease, acute illness within the past 2 weeks.

Cirrhosis (WP 3)

Inclusion criteria: Patients with clinical diagnosis of cirrhosis and indication for liver biopsy.

Exclusion criteria:Malignant disease, acute illness within the past 2 weeks.

Related Conditions & MeSH terms

• Cirrhosis
• Fatty Liver

Intervention

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

Locations

Country	Name	City	State
Denmark	Gastrounit, Copenhagen University Hospital Hvidovre	Hvidovre	Capital Region Denmark

Sponsors (2)

Lead Sponsor	Collaborator
Copenhagen University Hospital, Hvidovre	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial phosphoproteomic changes in liver tissue in healthy individuals	Phosphorproteomic changes will be performed using MS-based approach that allows identification of phosphorylations sites at proteins in the liver. The comparison will be done between 'fasted' and 'postprandial' samples	60 minutes after the meal administered at the study day
Secondary	Postprandial phosphoproteomic changes in liver tissue between healthy participants and patients with cirrhosis or patients with NAFLD.	Phosphorproteomic changes will be performed using MS-based approach that allows identification of phosphorylations sites at proteins in the liver. The comparison will be done between 'fasted' and 'postprandial' samples	60 minutes after the meal administered at the study day
Secondary	Postprandial proteomic, metabolomic and transcriptomic changes in liver tissue in healthy individuals and compared to patients with cirrhosis and patients with NAFLD	Proteomic, metabolomic and transcriptomic changes will be performed using MS-based approaches and Next generation sequencing that allows identification of proteins, metabolites, RNA-transcripts in the liver. The comparison will be done between 'fasted' and 'postprandial' samples	60 minutes after the meal administered at the study day
Secondary	Postprandial proteomic, metabolomic and Peptidomic changes in blood obtained from liver vein and peripheral vein in healthy individuals and compared to patients with cirrhosis and patients with NAFLD	Proteomic, metabolomic and hormonal changes will be performed using MS-based approaches and ELISAs that allows identification and measurements of proteins, metabolites and hormones from the liver. The comparison will be done between 'fasted' and 'postprandial' samples	120 minutes after the meal administered at the study day
Secondary	Effect of exogenous glucagon on changes in liver phosphoproteomics, proteomics, metabolomics, and transcriptomics in healthy individuals.	Proteomic, metabolomic and transcriptomic changes will be performed using MS-based approaches and Next generation sequencing that allows identification of proteins, metabolites, RNA-transcripts in the liver. The comparison will be done between 'fasted' and samples obtained after glucagon injection	30 minutes after the meal administered at the study day
Secondary	Effect of exogenous glucagon on changes in phosphoproteomics, proteomics, metabolomics and peptidomic in blood obtained from liver vein and peripheral vein in healthy individuals	Proteomic, metabolomic and hormonal changes will be performed using MS-based approaches and ELISAs that allows identification and measurements of proteins, metabolites and hormones from the liver. The comparison will be done between 'fasted' and samples obtained after glucagon injection	120 minutes after the meal administered at the study day

External Links

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