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临床试验/NCT05890365
NCT05890365招募中不适用

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

Steno Diabetes Center Copenhagen2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2023年12月14日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
2
主要终点
Liver fat content

研究概览

简要总结

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.

详细描述

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), 34-49 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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
34 Years 至 49 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

结局指标

主要结局

Liver fat content

时间窗: 0 minutes

Liver elastography (FibroScan) and validation by MRS

次要结局

  • Fasting insulin/C-peptide(0 minutes)
  • Liver fibrosis(0 minutes)
  • Fasting glucose(0 minutes)
  • Fasting liver enzymes(0 minutes)
  • Body composition(0 minutes)
  • Fasting lipids(0 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Charlotte Brøns

Principal investigator

Steno Diabetes Center Copenhagen

研究点 (2)

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