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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.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05890365
Enrollment
300
Registered
2023-06-06
Start date
2023-12-14
Completion date
2026-12-01
Last updated
2026-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Birth Weight, Non-Alcoholic Fatty Liver Disease

Keywords

Metabolic disease, Adipose tissue biology, Liver fat, Non-alcoholic fatty liver disease

Brief 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). 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.

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.

Interventions

None listed

Sponsors

Steno Diabetes Center Copenhagen
Lead SponsorOTHER
Aarhus University Hospital
CollaboratorOTHER
Lund University
CollaboratorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
34 Years to 49 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Liver fat content0 minutesLiver elastography (FibroScan) and validation by MRS

Secondary

MeasureTime frameDescription
Liver fibrosis0 minutesLiver elastography, validation by MR and liver histology
Body composition0 minutesDEXA
Fasting glucose0 minutesmmol/l
Fasting insulin/C-peptide0 minutespmol/l
Fasting lipids0 minutesmmol/l
Fasting liver enzymes0 minutesU/L

Countries

Denmark

Contacts

CONTACTCharlotte Brøns, PhD
charlotte.broens.01@regionh.dk+4526129093
STUDY_DIRECTORAllan Vaag, MD, PhD

Steno Diabetes Center Copenhagen

PRINCIPAL_INVESTIGATORCharlotte Brøns, PhD

Steno Diabetes Center Copenhagen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 12, 2026