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Non-alcoholic Fatty Liver Disease in Low Birth Weight Individuals

RecruitingNAAges 35 Years - 40 YearsAllSteno Diabetes Center Copenhagen
NCT05842850 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Caloric restriction intervention
  • No intervention
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Where

2 sites
Steno Diabetes Center Aarhus
Aarhus, Denmark
Steno Diabetes Center Copenhagen
Herlev, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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