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
Qualifiers
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
Treatments tested in this trial
- Caloric restriction intervention
- No intervention
Treatment groups
8 Participants
are divided into 1 treatment groupSponsors and collaborators
Steno Diabetes Center Copenhagen
Lead sponsor
Aarhus University Hospital
Collaborator
Lund University
Collaborator
Source ClinicalTrials.gov