Increased Risk of Non-alcoholic Fatty Liver Disease in Low Birth Weight Individuals

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-14

Study Completion Date

2025-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Non-alcoholic Fatty Liver Disease in Low Birth Weight Individuals

NCT05842850

NAFLD

NOT_YET_RECRUITING NA

De Novo Lipogenesis in Severity of NAFLD

NCT03683589

Nonalcoholic Fatty Liver Disease Nonalcoholic Steatohepatitis Bariatric Surgery Candidate +1 more

COMPLETED

Determinants of Liver Fat Composition

NCT03211299

Fatty Liver, Nonalcoholic Insulin Sensitivity

COMPLETED

Effects of Weight Loss on Hepatic and Muscle Lipid Content and on Insulin Sensitivity on Obese Adolescents With NAFLD

NCT00585299

Fatty Liver Insulin Resistance

COMPLETED NA

Effects of Dietary Nutrients on Liver and Adipose Tissue Metabolism

NCT03090347

NAFLD Nutrient; Excess

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

An adverse fetal environment characterized by low birth weight (LBW) plays a key role in the development of type 2 diabetes (T2D). The investigators recently demonstrated a 3-fold increase in liver fat in 26 early middle-aged LBW compared to 22 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). The investigators hypothesize that ectopic fat deposition and NAFLD is among the earliest disease manifestations and on the critical path to the development of more severe cardiometabolic disease in LBW. Here we aim to perform an extended nested case-control screening study to evaluate hepatic steatosis (NAFLD) and fibrosis in early middle-aged, non-obese LBW men and women and NBW controls. In total, 250 LBW men and women (birth weight (BW) \<10% of the population) and 50 NBW controls (BW between 50-90% of the population) born at term (weeks 39-41), 35-40 years-of-age will be recruited from the National Danish Birth Registry for the nested case-control NAFLD screening study. The nested case-control NAFLD screening study will serve as a recruitment platform for a subsequent intervention study.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-Alcoholic Fatty Liver Disease Low Birth Weight

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 250 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)

Exclusion Criteria

* 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

Minimum Eligible Age

35 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No