Community-based liver health assessment using noninvasive biomarkers
The Stratification of Liver Disease in the Community Using Fibrosis Biomarkers
This study is trying to see how well non-invasive tests can help identify liver health issues in people at risk, like those with diabetes or obesity, by gathering information from around 2,000 participants over four years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Nottingham Academic / other |
| Locations | 1 site (Nottingham, Notts) |
| Trial ID | NCT02037867 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to establish a community-based cohort of individuals at risk for liver disease, utilizing non-invasive biomarkers to assess liver disease severity. The study will recruit approximately 2,000 participants over four years, focusing on those with risk factors such as chronic liver disease, alcohol use disorder, type 2 diabetes, and obesity. Participants will undergo serum blood sampling, transient elastography, and qualitative interviews to evaluate liver health and potential lifestyle changes. The long-term follow-up will monitor liver and cardiovascular outcomes, providing valuable data for future interventions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and over with risk factors for liver disease, such as hazardous alcohol use, type 2 diabetes, obesity, or persistently elevated ALT levels.
Not a fit: Patients with active malignancy, inability to provide informed consent, or known histologically proven liver disease prior to enrollment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier identification and management of liver disease, potentially reducing morbidity and mortality associated with liver conditions.
How similar studies have performed: Previous studies have indicated that community-based approaches using non-invasive biomarkers can successfully identify significant liver disease that is often missed in clinical settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients aged 18 years or over (male or female) with primary risk factor for liver disease: * Hazardous alcohol use (\>14 units/week for women, \>21 units/week for men) * Type 2 Diabetes * Obesity * Persistently elevated ALT with normal liver serology Exclusion Criteria: * Active malignancy at study enrolment * Inability to provide informed consent for study enrolment * Known presence of histologically proven liver disease prior to pilot pathway participation
Where this trial is running
Nottingham, Notts
- NIHR Nottingham Digestive Diseases Biomedical Research Unit — Nottingham, Notts, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Neil Guha, MRCP, PhD — University of Nottingham
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.