Increased Risk of Non-alcoholic Fatty Liver Disease in Low Birth Weight Individuals
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age34-49
SponsorSteno Diabetes Center Copenhagen
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
BMI>35 kg/m2
Disease/medication known to affect primary outcome
Self-reported high physical activity level
Alcohol intake above general recommendations.
Trial 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.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Liver fat content
Liver elastography (FibroScan) and validation by MRS
Time frame
0 minutesSecondary outcomes
1
Liver fibrosis
Liver elastography, validation by MR and liver histology
Time frame
0 minutes2
Body composition
DEXA
Time frame
0 minutes3
Fasting glucose
mmol/l
Time frame
0 minutes4
Fasting insulin/C-peptide
pmol/l
Time frame
0 minutesOther outcomes
1
Transcriptomics in SAT and ex vivo cultured preadipocytes
RNAseq
Time frame
0 minutes2
Epigenetics of SAT and ex vivo cultured preadipocytes
Genome-wide DNA methylation
Time frame
0 minutes3
Functional characterization of lipid accumulation
Metabolism of ex vivo differentiated preadipocytes
Time frame
0 minutes4
Functional characterization of lipolysis
Metabolism of ex vivo differentiated preadipocytes
Time frame
0 minutesSponsors and contacts
Click on the lead sponsor to view all of their trials.
Steno Diabetes Center Copenhagen
Lead sponsor
Aarhus University Hospital
Collaborator
Lund University
Collaborator
Source ClinicalTrials.gov