Non-alcoholic Fatty Liver Disease in Low Birth Weight Individuals
ConditionNAFLD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-40
SponsorSteno Diabetes Center Copenhagen
About this trial
The investigators will conduct a proof-of-principle 4-weeks low-calorie diet (LCD) intervention study in low birth weight (LBW) subjects and normal birth weight (NBW) controls with documented (MR scan) liver fat content equal to or above 5%. The investigators will provide extended in-depth mechanistic insight into the role of impaired subcutaneous adipose tissue (SAT) expandability in ectopic fat deposition before and after LCD.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
subjects with NAFLD (liver fat content ≥5% liver fat content verified on MRS in the screening NAFLD study)
Disqualifiers
BMI<18.5 and 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
Trial design
Design model
Single group
Treatments tested in this trial
Caloric restriction intervention
BehavioralThe intervention consist of 4-weeks low calories diet (LCD) using total meal replacement from NUPO. A dietician will guide the participants an ensure well-being during the intervention.
No intervention
Other interventionNo intervention
Treatment groups
8 Participants
are divided into 1 treatment groupGroup A: individuals with MASLDExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Liver fat content
Validation by Magnetic resonance spectroscopy (MRS)
Time frame
Change from baseline in liver fat content at 4 weeks2
Liver fat content
Liver elastography (FibroScan)
Time frame
Change from baseline in liver fat content at 4 weeksSecondary outcomes
1
Liver stiffness
Liver elastography (FibroScan)
Time frame
Baseline and after 4 weeks2
Body composition
DEXA scan
Time frame
Baseline and after 4 weeksOther outcomes
1
Adipocyte size
Adipose tissue immunohistochemistry
Time frame
Baseline and after 4 weeks2
Collagen content
Adipose tissue immunohistochemistry
Time frame
Baseline and after 4 weeks3
Transcriptomics
RNAseq of bulk subcutaneous adipose tissue
Time frame
Baseline and after 4 weeks4
Transcriptomics
RNAseq of ex vivo cultured preadipocytes
Time frame
Baseline and after 4 weeksSponsors 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