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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Herlev, , Denmark
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