Diabetes, Metabolic Risk Factors, Autoimmunity and Self-reported Life Style Factors in Women With Previous Gestational Diabetes Mellitus (GDM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Type 2 diabetes
研究概览
简要总结
Women with previous Gestational Diabetes Mellitus (GDM) are characterized by several metabolic abnormalities i.e. insulin resistance, beta-cell dysfunction and increased risk of later Diabetes Mellitus (DM). These latent disorders of glucose metabolism are demasked by the metabolic stress of pregnancy and as a routine, clinical assessment and measurement of HbA1c in addition to an oral glucose tolerance test (OGTT) is offered 3 months post partum.
In this study, women with previous GDM and a control group matched on age, time of birth and BMI around 8 years after pregnancy will be investigated. Information from pregnancy and post partum examination (GDM only) will be used to identify risk factors for later development of DM. Further, life-style factors and mental health according to diabetes status will be studied.
详细描述
Background
It is well established that women with previous GDM are characterized by several metabolic abnormalities i.e. insulin resistance, beta-cell dysfunction and increased risk of later Diabetes Mellitus (DM). Furthermore, GDM is a heterogeneous condition covering both women with a strong genetic disposition to type 2 DM, women in the early stages of autoimmune DM and rare cases of monogenetic DM. These latent disorders of glucose metabolism are damasked by the metabolic stress of pregnancy.
Aims
- To study predictors of DM and pre-DM after GDM: a) At the time of pregnancy: age, blood pressure, pre-pregnancy Body Mass Index (BMI), b) 3 months post partum: indices of insulin sensitivity and beta-cell function, lipid profile, GAD-autoantibodies, HbA1c
- To study lifestyle factors 7-8 years after GDM pregnancy in relation to current diabetes status
Materials and methods
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Previous GDM with information from post partum OGTT
- •Danish speaking
排除标准
- •Bariatric surgery
- •Poorly controlled psychiatric disorder
结局指标
主要结局
Type 2 diabetes
时间窗: 7 to 8 years after giving birth
次要结局
- Questionnaires, physical activity (PAS 2), physical activity score(7 to 8 years after giving birth)
- Plasma glucose (mmol/l) at 0, 30 and 120 minutes during oral glucose tolerance test(7 to 8 years after giving birth)
- Serum insulin (mU/l) at 0, 30 and 120 minutes during oral glucose tolerance test(7 to 8 years after giving birth)
- Questionnaires, mental health (WHO-5), WHO-Five well being index(7 to 8 years after giving birth)
- Body mass index (kg/m2)(7 to 8 years after giving birth)
- Blood pressure (mmHg)(7 to 8 years after giving birth)
- Questionnaires, quality of life (SF12), physical and mental summary scores(7 to 8 years after giving birth)