RecruitingNot Applicable

Non-alcoholic Fatty Liver Disease in Low Birth Weight Individuals

Denmark8 participantsStarted 2026-01-01

Plain-language 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.

Who can participate

Age range35 Years – 40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Liver fat content

Timeframe: Change from baseline in liver fat content at 4 weeks

Liver fat content

Timeframe: Change from baseline in liver fat content at 4 weeks

Trial details

NCT IDNCT05842850

SponsorSteno Diabetes Center Copenhagen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Charlotte Brøns, PhD

+4526129093 charlotte.broens.01@regionh.dk

View on ClinicalTrials.gov More NAFLD trials