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Search / Trial NCT05890365

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

Launched by STENO DIABETES CENTER COPENHAGEN · May 26, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Metabolic Disease Adipose Tissue Biology Liver Fat Non Alcoholic Fatty Liver Disease

ClinConnect Summary

This clinical trial is studying the link between low birth weight and the risk of developing non-alcoholic fatty liver disease (NAFLD). Researchers have found that some individuals who were born with a low birth weight have higher amounts of fat in their liver compared to those with normal birth weight. In fact, 20% of those with low birth weight were found to have NAFLD that they didn't know about, while none of the normal birth weight individuals had this condition. The goal of this study is to further investigate this connection by inviting more participants.

To take part in this study, you need to be between 12 and 60 years old and have been born with a low birth weight, which means your birth weight was in the lowest 10% compared to others. The study will include 250 people with low birth weight and 50 people whose birth weight was normal. However, if you have a high body mass index (BMI), a family history of diabetes, certain medical conditions, or if you consume more alcohol than recommended, you may not be eligible. Participants will undergo assessments to check for liver health and will learn more about their own health in the process. This study is currently recruiting participants of all genders.

Gender

ALL

Eligibility 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

About Steno Diabetes Center Copenhagen

Steno Diabetes Center Copenhagen is a leading clinical research facility dedicated to advancing the understanding and treatment of diabetes and its complications. As a prominent sponsor of clinical trials, the center focuses on innovative research that bridges clinical practice and scientific inquiry, fostering collaborations with healthcare professionals, researchers, and patients. Committed to improving patient outcomes, Steno Diabetes Center Copenhagen emphasizes evidence-based approaches and cutting-edge methodologies to enhance diabetes management and care, ultimately contributing to the global fight against this chronic disease.

Locations

Herlev, , Denmark

Patients applied

0 patients applied

Trial Officials

Allan Vaag, MD, PhD

Study Director

Steno Diabetes Center Copenhagen

Charlotte Brøns, PhD

Principal Investigator

Steno Diabetes Center Copenhagen

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported