An observational study in Non-Alcoholic Fatty Liver Disease and Low Birth Weight, sponsored by Steno Diabetes Center Copenhagen. Recruiting at 1 site in Denmark. Open to participants aged 34 Years to 49 Years. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by Steno Diabetes Center Copenhagen · Observational
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.
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.
1,617 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 324 are open to participants now.
This study's planned enrollment of 300 is above the median of 153 across 390 observational studies indexed under Non-alcoholic Fatty Liver Disease.
Browse Non-alcoholic Fatty Liver Disease studies →Steno Diabetes Center Copenhagen is the lead sponsor of 113 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Liver fat content
Liver elastography (FibroScan) and validation by MRS
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Liver fibrosis
Liver elastography, validation by MR and liver histology
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Body composition
DEXA
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Fasting glucose
mmol/l
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Fasting insulin/C-peptide
pmol/l
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Fasting lipids
mmol/l
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Fasting liver enzymes
U/L
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Transcriptomics in SAT and ex vivo cultured preadipocytes
RNAseq
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Epigenetics of SAT and ex vivo cultured preadipocytes
Genome-wide DNA methylation
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Functional characterization of lipid accumulation
Metabolism of ex vivo differentiated preadipocytes
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Functional characterization of lipolysis
Metabolism of ex vivo differentiated preadipocytes
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Functional characterization of glycolysis
Metabolism of ex vivo differentiated preadipocytes
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Functional characterization of respiration
Metabolism of ex vivo differentiated preadipocytes
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Adipocyte size
Histology in SAT
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Adipocyte collagen content
Histology in SAT
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Immunohistochemical markers of fibrosis
Histology in SAT
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Immunohistochemical markers of senescence
Histology in SAT
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Immunohistochemical markers of inflammation
Histology in SAT
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Adipokine secretion of differentiating preadipocytes
Targeted adipokine analysis using immunoassay-based panels
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Started Dec 2023 (actual). Primary completion is estimated for Jun 2026, 30 months after the start.
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Non-alcoholic Fatty Liver Disease →
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