Metformin Experience on Minimal Hepatic Encephalopathy | NCT02470546

Studies
Metformin Experience on Minimal Hepatic Encephalopathy

NCT02470546

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Status

Unknown status

Last Update Posted

Jun 12, 2015Estimated

Enrollment

30Estimated

Phase

Phase 4

Conditions

Liver Cirrhosis
Hepatic Encephalopathy

Interventions

Metformin
Placebo

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Jun 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Sep 4, 2014

First Submission Date that Met QC Criteria

Jun 9, 2015

First Posted Date

Jun 12, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2015

Last Update Posted Date

Jun 12, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Primary aim:

-To assess the effect of metformin use on the treatment of minimal hepatic encephalopathy in patients with liver cirrhosis.

Secondary aim:

-To evaluate if metformin is a safety drug in patients showing liver cirrhosis.

Detailed Description

In this study, 30 patients will be included divided in two arms. Investigators and patients will not know the treatment used (double blind).

Arm 1: Metformin 1000mg twice a day (2000 mg/day), during 12 weeks. Arm 2: Placebo 1000mg twice a day (2000mg/day), during 12 weeks.

At the end of the study, patients will be followed-up 8 weeks more to control the appearance of adverse effects.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Metformin	Active Comparator	Patients receiving metformin	Drug: Metformin
Placebo	Placebo Comparator	Patients receiving placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Metformin	Drug	Metformin 1000mg twice a day	Metformin	Drug 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with Minimal hepatic encephalopathy	Measurement of the results of critical flicker frequency after 12 weeks of metformin treatment	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Number of patients with Minimal hepatic encephalopathy	Measurement of the results of PHES after 12 weeks of metformin treatment	12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with > 18 years old
Patients with the results of all the factors evaluable at the time of inclusion
Patients who have accepted their participation in the study through informed consent
Patients showing liver cirrhosis by ultrasound, transient elastography or liver biopsy
Patients showing minimal hepatic encephalopathy (PHES < 4 or Critical Flicker Frequency < 39 Hz)

Exclusion Criteria:

Patients with any contraindications to the drugs used
Patients showing type 1 diabetes mellitus
Patients showing type 2 diabetes mellitus and previous or current use of exogenous insulin, metformin or other oral antidiabetic drug

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Manuel Romero-Gomez, PhD, MD	Contact			mromerogomez@us.es

Overall Officials

Name	Affiliation	Role
Manuel Romero-Gomez, PhD, MD	Valme University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fundación Pública Andaluza para la Gestión de la investigación en salud de Sevilla (FISEVI)	Recruiting	Seville			Spain

Condition Browse Module

MeSH Terms

ID	Term
D008103	Liver Cirrhosis
D006501	Hepatic Encephalopathy

Ancestor Terms

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D005355	Fibrosis
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008687	Metformin

Ancestor Terms

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided