Non-alcoholic Fatty Liver Disease in Low Birth Weight Individuals
Recruiting · NCT05842850 · Interventional (participants receive a specific treatment) · Lead sponsor: Steno Diabetes Center Copenhagen
View the official record on ClinicalTrials.gov →Interventions studied
Caloric restriction interventionNo intervention
What this trial is about
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.
Who can take part
Age range
35 Years to 40 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- subjects with NAFLD (liver fat content ≥5% liver fat content verified on MRS in the screening NAFLD study)
Exclusion criteria
- 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
- Alcohol intake above general recommendations.
- Metabolic/liver disease
- Weight gain/loss of \>3 kg within the past 6 months
Where it is running
2 locations listed.
- Steno Diabetes Center Aarhus - Aarhus, Denmark
- Steno Diabetes Center Copenhagen - Herlev, Denmark