Steno Diabetes Center Copenhagen
Herlev, 2730, Denmark
Location status: Recruiting
Location contact
Allan Vaag, MD, PhD
CONTACT
Charlotte Brøns, PhD
PRINCIPAL_INVESTIGATOR
Charlotte Brøns, Phd
CONTACT
NCT Number: NCT05890365
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.
Interested in participating?
Request Info34 year–49 year
All sexes
Observational
Herlev, 2730, Denmark
Location status: Recruiting
Allan Vaag, MD, PhD
CONTACT
Charlotte Brøns, PhD
PRINCIPAL_INVESTIGATOR
Charlotte Brøns, Phd
CONTACT
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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Liver elastography (FibroScan) and validation by MRS
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Liver elastography, validation by MR and liver histology
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DEXA
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mmol/l
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pmol/l
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mmol/l
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U/L
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RNAseq
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Genome-wide DNA methylation
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Metabolism of ex vivo differentiated preadipocytes
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Metabolism of ex vivo differentiated preadipocytes
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Metabolism of ex vivo differentiated preadipocytes
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Metabolism of ex vivo differentiated preadipocytes
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Histology in SAT
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Histology in SAT
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Histology in SAT
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Histology in SAT
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Histology in SAT
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Targeted adipokine analysis using immunoassay-based panels
Contact information is provided by the study sponsor or research team.
Steno Diabetes Center Copenhagen
Other
Increased Risk of Non-alcoholic Fatty Liver Disease in Low Birth Weight Individuals - Extended Validation.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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