Non-Alcoholic Fatty Liver DiseaseNCT05890365
Increased Risk of Non-alcoholic Fatty Liver Disease in Low Birth Weight Individuals
An observational study of Non-Alcoholic Fatty Liver Disease and Low Birth Weight, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 34 to 49 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease, Low Birth Weight
- How many people
- 300 participants
- Where
- 1 siteDenmark
- Study dates
- 14 Dec 2023to Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 34 to 49 years
- All sexes
- Adult
Study population: Healthy men and women aged between 34-49 years born with a low (cases) and normal (controls) birth weight. All individuals have to be born at term in either the Copenhagen or Aarhus area.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Steno Diabetes Center Copenhagen
Herlev, 2730
Charlotte Brøns, Phd, +4526129093, charlotte.broens.01@regionh.dk
Allan Vaag, MD, PhD, +4520429660, allan.arthur.vaag@regionh.dk
About this study
Official title: Increased Risk of Non-alcoholic Fatty Liver Disease in Low Birth Weight Individuals - Extended Validation.
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.
Read the detailed description
An adverse fetal environment characterized by low birth weight (LBW) plays a key role in the development of type 2 diabetes (T2D). The investigators recently demonstrated a 3-fold increase in liver fat in 26 early middle-aged LBW compared to 22 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). The investigators hypothesize that ectopic fat deposition and NAFLD is among the earliest disease manifestations and on the critical path to the development of more severe cardiometabolic disease in LBW. Here we aim to perform an extended nested case-control screening study to evaluate hepatic steatosis (NAFLD) and fibrosis in early middle-aged, non-obese LBW men and women and NBW controls. In total, 250 LBW men and women (birth weight (BW) <10% of the population) and 50 NBW controls (BW between 50-90% of the population) born at term (weeks 39-41), 34-49 years-of-age will be recruited from the National Danish Birth Registry for the nested case-control NAFLD screening study. The nested case-control NAFLD screening study will serve as a recruitment platform for a subsequent intervention study.
- Keywords
- Metabolic disease, Adipose tissue biology, Liver fat, Non-alcoholic fatty liver disease
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Metabolic Diseases, Fatty Liver
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver fat content
Liver elastography (FibroScan) and validation by MRS
Measured: 0 minutes
Secondary outcomes (6)
Liver fibrosis
Liver elastography, validation by MR and liver histology
Measured: 0 minutes
Body composition
DEXA
Measured: 0 minutes
Fasting glucose
mmol/l
Measured: 0 minutes
Fasting insulin/C-peptide
pmol/l
Measured: 0 minutes
Fasting lipids
mmol/l
Measured: 0 minutes
Fasting liver enzymes
U/L
Measured: 0 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start14 Dec 2023
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Lund University
- Responsible party
- Principal investigator, Charlotte Brøns, Steno Diabetes Center Copenhagen
- Investigators
- Allan Vaag, MD, PhD, Study director, Steno Diabetes Center CopenhagenCharlotte Brøns, PhD, Principal investigator, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05890365
- Sponsor's protocol ID
- NAFLD validation
- Status last verified
- Apr 2026
- First submitted
- 2 Mar 2023
- Last updated
- 11 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No