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NCT05890365Recruiting

Increased Risk of Non-alcoholic Fatty Liver Disease in Low Birth Weight Individuals

Increased Risk of Non-alcoholic Fatty Liver Disease in Low Birth Weight Individuals - Extended Validation.

Source: ClinicalTrials.gov · Last updated 11 Jun 2026

Brief summary (registry, in English)

The investigators recently demonstrated a increase in liver fat in early middle-aged LBW compared to normal birth weight (NBW) men, and 20% of the LBW - but none of the normal birth weight (NBW) - men had previously unknown non-alcoholic fatty liver disease (NAFLD). Here the investigators will further examine the Increased risk of non-alcoholic fatty liver disease in low birth weight individuals by performing a validation study.

Status (registry)
Recruiting
Study type
Observational
Enrollment
300 (estimated)
First submitted
2 Mar 2023
Start date
14 Dec 2023
Primary completion date
Jun 2026
Lead sponsor
Steno Diabetes Center Copenhagen
NCT number
NCT05890365

What you commit to

  • Study type: Observational
  • Planned participants: 300
  • From 14 Dec 2023 to the primary completion date, Jun 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Disease/medication known to affect primary outcome
  • Metabolic/liver disease

Other

  • BMI\>35 kg/m2
  • Self-reported high physical activity level
  • Alcohol intake above general recommendations.
  • Weight gain/loss of \>3 kg within the past 6 months

Who the study is looking for

  • 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)

Age in the registry: 34 years to 49 years · Sex: All

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Steno Diabetes Center Copenhagen
Coordinator of this site? Confirm its status
HerlevDenmarkRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.