Liver CirrhosisPhase 4EMENCT02470546
Metformin Experience on Minimal Hepatic Encephalopathy
A Phase 4 study testing Metformin in people with Liver Cirrhosis and Hepatic Encephalopathy, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Cirrhosis, Hepatic Encephalopathy
- What is being tested?
- Metformin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2015to Dec 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Manuel Romero-Gomez, PhD, MD contact
Spain1 site, 1 recruiting
- Recruiting
Fundación Pública Andaluza para la Gestión de la investigación en salud de Sevilla (FISEVI)
Seville
Manuel Romero-Gomez, PhD, MD, mromerogomez@us.es
Javier Ampuero, MD
About this study
Official title: Metformin Experience on Minimal Hepatic Encephalopathy in Patients With Liver Cirrhosis
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.
Read the 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.
- Conditions
- Liver Cirrhosis, Hepatic Encephalopathy
- Being tested
- Metformin, Placebo
- Keywords
- Hepatic encephalopathy, Metformin, Liver cirrhosis
- Medical subject headings
- Liver Cirrhosis, Hepatic Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Drug 1
Metformin 1000mg twice a day
PlaceboDrug
Also called Drug 2
Placebo 1000mg twice a day
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Active comparator | Patients receiving metformin Receives: Drug: Metformin |
| Placebo | Placebo comparator | Patients receiving placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with Minimal hepatic encephalopathy
Measurement of the results of critical flicker frequency after 12 weeks of metformin treatment
Measured: 12 weeks
Secondary outcomes (1)
Number of patients with Minimal hepatic encephalopathy
Measurement of the results of PHES after 12 weeks of metformin treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manuel Romero-Gomez, PhD, MD, Principal investigator, Valme University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02470546
- Sponsor's protocol ID
- EME-2015
- Acronym
- EME
- Status last verified
- Jun 2015
- First submitted
- 4 Sep 2014
- Last updated
- 12 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metformin Experience on Minimal Hepatic Encephalopathy in Patients With Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT02470546
- Acronym / sponsor ID
- EME / EME-2015
- Conditions
- Liver Cirrhosis, Hepatic Encephalopathy
- Keywords
- Hepatic encephalopathy, Metformin, Liver cirrhosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 12 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin | Active comparator | Drug: MetforminPatients receiving metformin |
| Placebo | Placebo comparator | Drug: PlaceboPatients receiving placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminAlso: Drug 1Metformin 1000mg twice a day | Drug | Metformin |
| PlaceboAlso: Drug 2Placebo 1000mg twice a day | Drug | Placebo |
Primary outcome
Number of patients with Minimal hepatic encephalopathy
Time frame: 12 weeks
Measurement of the results of critical flicker frequency after 12 weeks of metformin treatment
1 secondary outcome
Number of patients with Minimal hepatic encephalopathy
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel Romero-Gomez, PhD, MD contact
Manuel Romero-Gomez, PhD, MD principal investigator
Valme University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metformin in people with Liver Cirrhosis and Hepatic Encephalopathy, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manuel Romero-Gomez, PhD, MD (mromerogomez@us.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with Minimal hepatic encephalopathy (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2015.