Fatty LiverNCT04022681
Long-term Follow Up of Patients in the Birmingham and Lambeth Liver Evaluation Strategies (BALLETS) Study
An observational study of Fatty Liver and Liver Diseases, run by University of Warwick.
Trial summary
This study will follow-up a cohort of patients from the Birmingham and Lambeth Liver Evaluation Strategies (BALLETS) study using a database search based on their individual National Health Service (NHS) numbers. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Fatty Liver, Liver Diseases
- What is being tested?
- BALLETS
- How many people
- 1,237 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2005to 1 Jul 2013
- Phase
- Observational
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in primary care with no known liver disease, who had a liver function test (LFT)
Who may be able to join
- Adult with abnormal liver function test (LFT) result
Who cannot join
- Pre-existing or obvious liver disease
About this study
This study will follow-up a cohort of patients from the Birmingham and Lambeth Liver Evaluation Strategies (BALLETS) study using a database search based on their individual National Health Service (NHS) numbers. The investigators will interrogate the Hospital Episode Statistics database and the Office of National Statistics database, and examine three categories of end points: death, inpatient attendance primarily due to liver disease, and outpatient attendance primarily due to liver disease.
A logistic regression analysis will then be conducted to determine associations between these end points and the presence, and degree, of fatty liver in the original BALLETS study, adjusted for age, sex, alcohol intake, BMI, and baseline ALT measurement.
Read the detailed description
The Birmingham and Lambeth Liver Evaluation Strategies (BALLETS) study was a prospective study of people in General Practice who had an abnormal liver function test result. Recruitment took place between 2005 and 2008, and patients were able to be grouped into four primary categories: hepato-cellular disease, hepato-biliary disease, tumour, non-specific with or without fatty liver. This study will focus on the fourth, non-specific, group of which there were 1,237 patients.
This study will follow-up this cohort of patients using a database search based on their individual National Health Service (NHS) numbers. The investigators will interrogate the Hospital Episode Statistics database (health outcomes) and the Office of National Statistics database (death), and examine three categories of end points: death, inpatient attendance primarily due to liver disease, and outpatient attendance primarily due to liver disease. Deaths would be sub-categorised as including liver disease, or not.
A logistic regression analysis will then be conducted to determine associations between these end points and the presence, and degree, of fatty liver in the original BALLETS study, with adjustment for age and sex. Similar age- and sex-adjusted analyses will be conducted to investigate the association with other patient risk factors - alcohol intake and BMI. The analyses will be repeated incorporating an additional adjustment for baseline Alanine Aminotransferase (ALT) measurement.
- Conditions
- Fatty Liver, Liver Diseases
- Being tested
- BALLETS
- Medical subject headings
- Fatty Liver, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BALLETSOther
Cohort were not exposed to any intervention. There information will be analysed from database searches.
| Study group | Role | What they receive |
|---|---|---|
| Non-specific liver disease | Patients who were categorised as having a non-specific liver disease in the original BALLETS study. Receives: Other: BALLETS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients who Died
Death of patient, sub-categorised as either including liver disease, or liver disease not mentioned
Measured: From date of recruitment until the date of death, up to 14 years
Secondary outcomes (2)
Number of patients attending inpatient department, primary reason liver disease
Number of patients attending hospital inpatient department, with their primary reason for attendance being liver disease, as measured by the hospital episode statistics database.
Measured: From date of recruitment until the date of database search, up to 14 years
Number of patients attending outpatient department, primary reason liver disease
Number of patients attending hospital outpatient department, with their primary reason for attendance being liver disease, as measured by the hospital episode statistics database.
Measured: From date of recruitment until the date of database search, up to 14 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start1 Dec 2005
- Primary completion1 May 2010
- Study completion1 Jul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fatty LiverStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,237 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Warwick
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Birmingham
- Responsible party
- Principal investigator, Professor Richard Lilford, University of Warwick
- Investigators
- Richard J Lilford, FMedSci, Principal investigator, University of Warwick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04022681
- Sponsor's protocol ID
- BALLETS-LT-Followup
- Status last verified
- Jul 2019
- First submitted
- 12 Jul 2019
- Last updated
- 17 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data is not available to be shared.
Publications
Lilford RJ, Bentham L, Girling A, Litchfield I, Lancashire R, Armstrong D, Jones R, Marteau T, Neuberger J, Gill P, Cramb R, Olliff S, Arnold D, Khan K, Armstrong MJ, Houlihan DD, Newsome PN, Chilton PJ, Moons K, Altman D. Birmingham and Lambeth Liver Evaluation Testing Strategies (BALLETS): a prospective cohort study. Health Technol Assess. 2013 Jul;17(28):i-xiv, 1-307. doi: 10.3310/hta17280.
PubMed 23834998
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow Up of Patients in the Birmingham and Lambeth Liver Evaluation Strategies (BALLETS) Study
- ClinicalTrials.gov ID
- NCT04022681
- Acronym / sponsor ID
- BALLETS-LT-Followup
- Conditions
- Fatty Liver, Liver Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,237 participants (actual)
- Lead sponsor
- University of WarwickUniversity, hospital or other
- Collaborators
- University Hospital Birmingham
- Study start
- 1 Dec 2005 (actual)
- Primary completion
- 1 May 2010 (actual)
- Study completion
- 1 Jul 2013 (actual)
- First posted
- 17 Jul 2019 (actual)
- 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.
This study will follow-up a cohort of patients from the Birmingham and Lambeth Liver Evaluation Strategies (BALLETS) study using a database search based on their individual National Health Service (NHS) numbers. The investigators will interrogate the Hospital Episode Statistics database and the Office of National Statistics database, and examine three categories of end points: death, inpatient attendance primarily due to liver disease, and outpatient attendance primarily due to liver disease.
A logistic regression analysis will then be conducted to determine associations between these end points and the presence, and degree, of fatty liver in the original BALLETS study, adjusted for age, sex, alcohol intake, BMI, and baseline ALT measurement.
Detailed description
The Birmingham and Lambeth Liver Evaluation Strategies (BALLETS) study was a prospective study of people in General Practice who had an abnormal liver function test result. Recruitment took place between 2005 and 2008, and patients were able to be grouped into four primary categories: hepato-cellular disease, hepato-biliary disease, tumour, non-specific with or without fatty liver. This study will focus on the fourth, non-specific, group of which there were 1,237 patients.
This study will follow-up this cohort of patients using a database search based on their individual National Health Service (NHS) numbers. The investigators will interrogate the Hospital Episode Statistics database (health outcomes) and the Office of National Statistics database (death), and examine three categories of end points: death, inpatient attendance primarily due to liver disease, and outpatient attendance primarily due to liver disease. Deaths would be sub-categorised as including liver disease, or not.
A logistic regression analysis will then be conducted to determine associations between these end points and the presence, and degree, of fatty liver in the original BALLETS study, with adjustment for age and sex. Similar age- and sex-adjusted analyses will be conducted to investigate the association with other patient risk factors - alcohol intake and BMI. The analyses will be repeated incorporating an additional adjustment for baseline Alanine Aminotransferase (ALT) measurement.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-specific liver disease | – | Other: BALLETSPatients who were categorised as having a non-specific liver disease in the original BALLETS study. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in primary care with no known liver disease, who had a liver function test (LFT)
Key inclusion criteria (1 listed)
- Adult with abnormal liver function test (LFT) result
Key exclusion criteria (1 listed)
- Pre-existing or obvious liver disease
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 |
|---|---|---|
| BALLETSCohort were not exposed to any intervention. There information will be analysed from database searches. | Other | Non-specific liver disease |
Primary outcome
Number of Patients who Died
Time frame: From date of recruitment until the date of death, up to 14 years
Death of patient, sub-categorised as either including liver disease, or liver disease not mentioned
2 secondary outcomes
Number of patients attending inpatient department, primary reason liver disease
Time frame: From date of recruitment until the date of database search, up to 14 years
Number of patients attending outpatient department, primary reason liver disease
Time frame: From date of recruitment until the date of database search, up to 14 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
- Background: PubMed 23834998Lilford RJ, Bentham L, Girling A, Litchfield I, Lancashire R, Armstrong D, Jones R, Marteau T, Neuberger J, Gill P, Cramb R, Olliff S, Arnold D, Khan K, Armstrong MJ, Houlihan DD, Newsome PN, Chilton PJ, Moons K, Altman D. Birmingham and Lambeth Liver Evaluation Testing Strategies (BALLETS): a prospective cohort study. Health Technol Assess. 2013 Jul;17(28):i-xiv, 1-307. doi: 10.3310/hta17280.
- Individual participant dataSharing planned: No. Individual participant data is not available to be shared.
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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.
Richard J Lilford, FMedSci principal investigator
University of Warwick
Questions about this trial
What is this clinical trial studying?
An observational study of Fatty Liver and Liver Diseases, run by University of Warwick.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 17 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients who Died (time frame: From date of recruitment until the date of death, up to 14 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04022681, which also lists 1 linked publication.
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 17 Jul 2019.