Investigating liver disease risk in individuals with low birth weight
Official title: Increased Risk of Non-alcoholic Fatty Liver Disease in Low Birth Weight Individuals - Extended Validation.
Run by Steno Diabetes Center Copenhagen · NCT05890365 · Data updated 2026-11-12
This study is trying to see if people who were born with low birth weight are more likely to develop liver disease later in life compared to those who were born with normal weight.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 34 Years to 49 Years |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Steno Diabetes Center Copenhagen Academic / other |
| Locations | 1 site (Herlev) |
| Status | Recruiting |
| Started | December 14, 2023 |
| Main results expected | June 2026 |
| Study ends | December 2026 |
| Registry record updated | June 11, 2026 |
| Trial ID | NCT05890365 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include healthy men and women aged 35-40 years who were born with low birth weight (less than the 10th percentile) or normal birth weight (between the 50th and 90th percentiles).
✕Probably not a fit
Patients with a BMI over 35 kg/m2, metabolic or liver diseases, or those with significant weight fluctuations in the past six months may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to validate the increased risk of non-alcoholic fatty liver disease (NAFLD) in individuals with low birth weight (LBW) compared to those with normal birth weight (NBW). The researchers will conduct a nested case-control screening study involving 250 LBW participants and 50 NBW controls, all born at term and aged 35-40 years. The study will assess hepatic steatosis and fibrosis to understand the early manifestations of cardiometabolic diseases in LBW individuals. The findings may provide insights into the relationship between birth weight and liver health.
Why it matters
Potential benefit: If successful, this study could lead to early identification and management of liver disease in individuals with low birth weight.
How similar studies have gone: Previous studies have indicated a correlation between low birth weight and increased liver fat, suggesting that this approach may yield valuable insights into NAFLD risk.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 250 healthy, men and women born with a low birth weight (birth weight (BW) \<10% of the population) and 50 born with a normal birth weight controls (BW between 50-90% of the population) * born at term (weeks 39-41) Exclusion Criteria: * BMI\>35 kg/m2 * Disease/medication known to affect primary outcome * Self-reported high physical activity level * Alcohol intake above general recommendations. * Metabolic/liver disease * Weight gain/loss of \>3 kg within the past 6 months
Where it's running
-
Steno Diabetes Center Copenhagen
Herlev, Denmark Recruiting
Study contacts
- Principal investigator: Charlotte Brøns, PhD — Steno Diabetes Center Copenhagen
- Study coordinator: Charlotte Brøns, PhD
- Email: charlotte.broens.01@regionh.dk
- Phone: +4526129093
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.