NCT05890365

Brief Summary

The investigators recently demonstrated a increase in liver fat in early middle-aged LBW compared to normal birth weight (NBW) men, and 20% of the LBW - but none of the normal birth weight (NBW) - men had previously unknown non-alcoholic fatty liver disease (NAFLD). Here the investigators will further examine the Increased risk of non-alcoholic fatty liver disease in low birth weight individuals by performing a validation study.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Dec 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Dec 2023Dec 2026

First Submitted

Initial submission to the registry

March 2, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 6, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

December 14, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

2.5 years

First QC Date

March 2, 2023

Last Update Submit

April 22, 2026

Conditions

Non-Alcoholic Fatty Liver DiseaseLow Birth Weight

Keywords

Metabolic diseaseAdipose tissue biologyLiver fatNon-alcoholic fatty liver disease

Outcome Measures

Primary Outcomes (1)

  • Liver fat content

    Liver elastography (FibroScan) and validation by MRS

    0 minutes

Secondary Outcomes (6)

  • Liver fibrosis

    0 minutes

  • Body composition

    0 minutes

  • Fasting glucose

    0 minutes

  • Fasting insulin/C-peptide

    0 minutes

  • Fasting lipids

    0 minutes

  • +1 more secondary outcomes

Other Outcomes (12)

  • Transcriptomics in SAT and ex vivo cultured preadipocytes

    0 minutes

  • Epigenetics of SAT and ex vivo cultured preadipocytes

    0 minutes

  • Functional characterization of lipid accumulation

    0 minutes

  • +9 more other outcomes

Eligibility Criteria

Age35 Years - 40 Years
Sexall(Gender-based eligibility)
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy men and women aged between 35-40 years born with a low (cases) and normal (controls) birth weight. All individuals have to be born at term in either the Copenhagen or Aarhus area.

You may qualify if:

  • healthy, men and women born with a low birth weight (birth weight (BW) \<10% of the population) and 50 born with a normal birth weight controls (BW between 50-90% of the population)
  • born at term (weeks 39-41)

You may not qualify if:

  • BMI\>35 kg/m2
  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Steno Diabetes Center Copenhagen

Herlev, 2730, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Abdominal subcutaneous adipose tissue biopsies are retained

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseMetabolic DiseasesFatty Liver

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesNutritional and Metabolic Diseases

Study Officials

  • Allan Vaag, MD, PhD

    Steno Diabetes Center Copenhagen

    STUDY DIRECTOR

  • Charlotte Brøns, PhD

    Steno Diabetes Center Copenhagen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte Brøns, PhD

CONTACT

+4526129093charlotte.broens.01@regionh.dk

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 2, 2023

First Posted

June 6, 2023

Study Start

December 14, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 27, 2026

Record last verified: 2026-04

Locations

DK(1)