Effects of Metformin on portal hypertension in patients with cirrhosis.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-001132-19-DK

Enrollment

Registered

2017-04-21

Start date

2017-07-04

Completion date

Unknown

Last updated

2020-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cirrhosis and portal hypertension MedDRA version: 20.0 Level: HLT Classification code 10036201 Term: Portal hypertensions System Organ Class: 100000004866 MedDRA version: 20.0 Level: LLT Classification code 10009211 Term: Cirrhosis liver System Organ Class: 100000004871

Interventions

Trade Name: Metformin Product Name: Metformin Pharmaceutical Form: Soluble tablet INN or Proposed INN: METFORMIN CAS Number: 657-24-9 Concentration unit: mg milligram(s) Concentration type: equal Conc

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

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

Countries

Denmark

Contacts

Public ContactSteno Diabetes Center Aarhus

Aarhus University Hospital

nikolaj.rittig@clin.au.dk4561714731

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026