Environmental Versus Genetic and Epigenetic Influences on Growth, Metabolism and Cognitive Function in Offspring of Mothers With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 584
- 试验地点
- 3
- 主要终点
- Overweight
研究概览
简要总结
There is an increasing trend in the society for developing obesity, type 2 diabetes and cardiovascular diseases. It is therefore important to identify the risk factors behind this tendency. Recent studies have shown that exposure to high blood sugar levels in pregnancy (as in mothers with type 1 diabetes) may play a role in the development of obesity, type 2 diabetes and cardiovascular diseases later in life for the children. Some studies suggest that high blood sugar levels during pregnancy can also affects cognitive function as well as growth and development of puberty. The mechanisms behind this are not sufficiently clarified yet.
In the period 1993-1999, pregnant women with type 1 diabetes in Denmark were followed and information about the course of pregnancy was collected, including the long-term blood sugar level during pregnancy and the children's' condition at birth. The unique opportunities in Denmark to identify and follow the children of these mothers and the possibility to select a comparison group of children of non-diabetic mothers gives a unique opportunity to examine the children of mothers with type 1 diabetes and accurately investigate the effect of blood sugar levels in pregnancy on conditions later in life.
There has not previously been made any study of this size and it is the investigators hope to be able to quantify the effect of blood sugar level during pregnancy on outcomes later in life. This will potentially give the possibility to detect individuals at risk for cardiovascular diseases earlier and to improve prevention targets in children of mothers with diabetes.
详细描述
Introduction
Health conditions result from a combination of genetic susceptibility and environmental influences. While the genotype is determined at conception the phenotype is modulated and influenced by environmental and epigenetic factors throughout life, not only postnatally but already in uteri and possibly even at preimplantation stages.
Recent studies have highlighted the possible role of intrauterine exposure to maternal diabetes in the pathogenesis of overweight, type 2 diabetes and cardiovascular disease. A hyperglycaemic intrauterine environment may also affect cognitive function, childhood growth and pubertal development in the offspring. During 1993-99 all pregnancies in women with pre-gestational type 1 diabetes were prospectively reported to a national registry in the Danish Diabetes Association. This nationwide registry contain detailed information of maternal demography, pregnancy outcome and diabetes status including glycated haemoglobin (HbA1c) in a prospective cohort of 900 women and their newborn offspring. These data are therefore ideal for a large-scale study on long-term effects of a diabetic intrauterine environment.
The study consists of 3 substudies.
Aims
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 13 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children (diabetes exposed) from the national diabetes birth registry born between 1993 and 1999 (approximately n = 450) The same number of controls from the Central Person Register matched according to gender, age and postcode.
排除标准
- •Offspring with major handicaps or chronic disease will be registered, but will not be examined.
- •Multiple pregnancies and recurrent pregnancies will not be included in the study.
结局指标
主要结局
Overweight
时间窗: 0 - 18 years
Weight (\> 85-percentile for age and gender)
Diabetes/prediabetes
时间窗: 0 - 18 years
Assessed by Oral Glucose Tolerance Test
Cognitive functions
时间窗: 0 - 18 years
Assessed by RIAS-test and Conners' CPT II.
Pubertal development
时间窗: 0 - 18 years
次要结局
- BMI(0 - 18 years)
- Markers of endothelial function(0 - 18 years)
- Markers of autoimmunity(0 - 18 years)
- PCOS(0 - 18 years)
- Body composition(0 - 18 years)
- Blood pressure(0 - 18 years)
- Dyslipidemia(0 - 18 years)
- Insulin levels(0 - 18 years)
研究者
Zuzana Vlachová, MD
Cand. med.
Odense University Hospital