Increased Risk of Non-alcoholic Fatty Liver Disease in Low Birth Weight Individuals

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:

Increased Risk of Non-alcoholic Fatty Liver Disease in Low Birth Weight Individuals - Extended Validation.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05890365
• Other study ID #: NAFLD validation
• Status: Recruiting
• Start date: December 14, 2023
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Steno Diabetes Center Copenhagen
• Contact: Charlotte Brøns, PhD
• Phone: +4526129093
• Email: charlotte.broens.01[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

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), 35-40 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Gender: All
• Age group: 35 Years to 40 Years

Eligibility

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>30 kg/m2

• Family history of diabetes (siblings, parent, and grandparents)

• 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

Related Conditions & MeSH terms

• Birth Weight
• Body Weight
• Fatty Liver
• Liver Diseases
• Low Birth Weight
• Non-Alcoholic Fatty Liver Disease

Locations

Country	Name	City	State
Denmark	Steno Diabetes Center Copenhagen	Herlev

Sponsors (3)

Lead Sponsor	Collaborator
Steno Diabetes Center Copenhagen	Aarhus University Hospital, Lund University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Transcriptomics in SAT and ex vivo cultured preadipocytes	RNAseq	0 minutes
Other	Epigenetics of SAT and ex vivo cultured preadipocytes	Genome-wide DNA methylation	0 minutes
Other	Functional characterization of lipid accumulation	Metabolism of ex vivo differentiated preadipocytes	0 minutes
Other	Functional characterization of lipolysis	Metabolism of ex vivo differentiated preadipocytes	0 minutes
Other	Functional characterization of glycolysis	Metabolism of ex vivo differentiated preadipocytes	0 minutes
Other	Functional characterization of respiration	Metabolism of ex vivo differentiated preadipocytes	0 minutes
Other	Adipocyte size	Histology in SAT	0 minutes
Other	Adipocyte collagen content	Histology in SAT	0 minutes
Other	Immunohistochemical markers of fibrosis	Histology in SAT	0 minutes
Other	Immunohistochemical markers of senescence	Histology in SAT	0 minutes
Other	Immunohistochemical markers of inflammation	Histology in SAT	0 minutes
Other	Adipokine secretion of differentiating preadipocytes	Targeted adipokine analysis using immunoassay-based panels	0 minutes
Primary	Liver fat content	Liver elastography (FibroScan) and validation by MRS	0 minutes
Secondary	Liver fibrosis	Liver elastography, validation by MR and liver histology	0 minutes
Secondary	Body composition	DEXA	0 minutes
Secondary	Fasting glucose	mmol/l	0 minutes
Secondary	Fasting insulin/C-peptide	pmol/l	0 minutes
Secondary	Fasting lipids	mmol/l	0 minutes
Secondary	Fasting liver enzymes	U/L	0 minutes