Effects of Metformin on portal hypertension in patients with cirrhosis.

Phase 1

• Conditions: cirrhosis and portal hypertension; MedDRA version: 20.0Level: HLTClassification code 10036201Term: Portal hypertensionsSystem Organ Class: 100000004866; MedDRA version: 20.0Level: LLTClassification code 10009211Term: Cirrhosis liverSystem Organ Class: 100000004871; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2017-001132-19-DK
• Lead Sponsor: Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-21
• Last Update Posted: 7 December 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

-age> 18 years
-diagnosed with cirrhosis
-informed consent
-clinical indication for liver vein catherisation (LVC) and/or transjugular
intrahepatic portosystemic shunt (TIPS)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 44
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

servere liver disease (Child Pugh class 12-15)
pregnancy
incable to understand or read Danish
side effects og allergies to Metformin

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Main objective of the study is to investigate if Metformin lowers portal<br>blood pressure in patients with cirrhosis.<br><br>;Secondary Objective: The effect/changes of Metformin on intestine and liver<br>;Primary end point(s): Changes in portal pressure during LVC (Metformin vs placebo)<br>Changes in Plasma lactate concentration in v. porta before/after Metformin;Timepoint(s) of evaluation of this end point: 90 minutes after oral consumption<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Metabolic changes in the intestine (arterial blood - v. porta) and liver (v.<br>porta - v. hepatica):<br>Lactate, glucose, purovate, ketones, H+(pH), cytokines, Metformin, TNF-<br>a, insulin, glucagon, GLP-1, GIP, VIP, ammonium, FGF-21 and amino<br>acids.<br>;Timepoint(s) of evaluation of this end point: 90 minutes after oral consumption<br>