Liver fat in people born with low birth weight
Official title: Increased Risk of Non-alcoholic Fatty Liver Disease in Low Birth Weight Individuals - Reversibility and Mechanistic Studies.
Run by Steno Diabetes Center Copenhagen · NCT05842850 · Data updated 2026-11-12
A 4-week low-calorie diet to see if cutting calories lowers liver fat in middle-aged adults born with low birth weight who have NAFLD.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 35 Years to 40 Years |
| Sex | All |
| Enrollment | 8 (estimated) |
| Sponsor | Steno Diabetes Center Copenhagen Academic / other |
| Locations | 2 sites (Aarhus and 1 other locations) |
| Status | Recruiting |
| Started | January 1, 2026 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | May 4, 2026 |
| Trial ID | NCT05842850 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are early middle-aged, non-obese adults born with low birth weight who have liver fat ≥5% on MR spectroscopy and meet the study's medication, alcohol, and activity criteria.
✕Probably not a fit
People with BMI <18.5 or >30 kg/m2, existing metabolic or liver disease, high alcohol intake, recent significant weight change, or a strong family history of diabetes are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The project will screen about 250 early middle-aged, non-obese adults born with low birth weight using MR spectroscopy to identify those with liver fat ≥5%. Participants with elevated liver fat will enter a proof-of-principle 4-week low-calorie diet intervention with detailed metabolic phenotyping before and after the diet, including MR imaging, adipose tissue sampling, insulin secretion and sensitivity measures, and energy-expenditure testing. The investigators will compare responses in low birth weight versus normal birth weight controls to determine whether limited subcutaneous adipose tissue expandability explains greater ectopic liver fat in the low birth weight group. The work is focused on mechanistic insight and short-term liver fat change rather than long-term clinical outcomes, to inform targeted prevention strategies.
Why it matters
Potential benefit: If successful, this could show that short-term calorie restriction rapidly reduces liver fat in high-risk low birth weight adults and help prevent progression to more serious cardiometabolic disease.
How similar studies have gone: Short-term low-calorie diets have been shown to rapidly reduce liver fat in broader NAFLD populations, but applying this approach specifically to low birth weight individuals and linking effects to subcutaneous adipose tissue expandability is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Steno Diabetes Center Aarhus
Aarhus, Denmark Recruiting -
Steno Diabetes Center Copenhagen
Herlev, Denmark Recruiting
Study contacts
- Principal investigator: Charlotte Brøns, PhD — Steno Diabetes Center Copenhagen
- Study coordinator: Charlotte Brøns, PhD
- Email: charlotte.broens.01@regionh.dk
- Phone: +4526129093
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.