NCT05842850 Non-alcoholic Fatty Liver Disease in Low Birth Weight Individuals
| NCT ID | NCT05842850 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Steno Diabetes Center Copenhagen |
| Condition | NAFLD |
| Study Type | INTERVENTIONAL |
| Enrollment | 8 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 8 participants in total. It began in 2026-01-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Charlotte Brøns, PhD
PRINCIPAL INVESTIGATOR
Steno Diabetes Center Copenhagen
Frequently Asked Questions
Who can join the NCT05842850 clinical trial?
This trial is open to participants of all sexes, aged 35 Years or older, up to 40 Years, studying NAFLD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05842850 currently recruiting?
Yes, NCT05842850 is actively recruiting participants. Contact the research team at charlotte.broens.01@regionh.dk for enrollment information.
Where is the NCT05842850 trial being conducted?
This trial is being conducted at Aarhus, Denmark, Herlev, Denmark.
Who is sponsoring the NCT05842850 clinical trial?
NCT05842850 is sponsored by Steno Diabetes Center Copenhagen. The principal investigator is Charlotte Brøns, PhD at Steno Diabetes Center Copenhagen. The trial plans to enroll 8 participants.