Non-alcoholic Fatty Liver Disease in Low Birth Weight Individuals
Condition(s) studied
Investigational drug(s) / intervention(s)
Caloric restriction intervention: The 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: No intervention
Study summary
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
Primary outcome measure(s)
- Liver fat content — Change from baseline in liver fat content at 4 weeks
Validation by Magnetic resonance spectroscopy (MRS) - Liver fat content — Change from baseline in liver fat content at 4 weeks
Liver elastography (FibroScan)
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Steno Diabetes Center Aarhus | Aarhus | Denmark | Recruiting |
| Steno Diabetes Center Copenhagen | Herlev | Denmark | Recruiting |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05842850 on ClinicalTrials.gov ↗ ← All trials in Denmark