RecruitingNot ApplicableNCT05842850

Non-alcoholic Fatty Liver Disease in Low Birth Weight Individuals

Increased Risk of Non-alcoholic Fatty Liver Disease in Low Birth Weight Individuals - Reversibility and Mechanistic Studies.


Sponsor

Steno Diabetes Center Copenhagen

Enrollment

8 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 35 YearsMax Age: 40 Years

Inclusion Criteria1

  • subjects with NAFLD (liver fat content ≥5% liver fat content verified on MRS in the screening NAFLD study)

Exclusion Criteria7

  • 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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Interventions

BEHAVIORALCaloric 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.

OTHERNo intervention

No intervention


Locations(2)

Steno Diabetes Center Aarhus

Aarhus, Denmark

Steno Diabetes Center Copenhagen

Herlev, Denmark

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NCT05842850


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