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Non-alcoholic Fatty Liver Disease in Low Birth Weight Individuals

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv5
  2. Trial status: Not Yet Recruiting to Recruitingv4 Show 8 more changesShow less
    • Enrollment target: 24 to 8
    • Primary and study completion dates: Dec 2025 to Dec 2026
    • Start date changed from estimate of Feb 1, 2025 to Jan 1, 2026
    • Study sites: 0 to 2
    • Eligibility criteria shortened, about 10 words
    • Secondary endpoints: 8 to 2
    • Study description expanded, about 36 words
    • Study arms: 2 to 1
  3. Start date: Aug 2024 to Feb 1, 2025
    • Primary and study completion dates: Aug 2025 to Dec 2025
    v3
  4. Primary and study completion dates: Jun 2024 to Aug 2025
    • Start date: Dec 2023 to Aug 2024
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05842850
Lead Sponsor Steno Diabetes Center Copenhagen
Collaborators: Aarhus University Hospital, Lund University
Conditions
(from sponsor)		 NAFLD
Related terms Insulin Resistance, Non-alcoholic Fatty Liver Disease
Enrollment 8 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov