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临床试验/NCT04270578
NCT04270578招募中不适用

German Study Gestational Diabetes (PREG)

University Hospital Tuebingen1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2012年5月23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
800
试验地点
1
主要终点
Glucose tolerance during 75 g oral glucose tolerance test

研究概览

简要总结

Due to a changed lifestyle with less physical activity, unfavorable diets rich in fat and calories and obesity, the prevalence of diabetes mellitus is increasing worldwide. The diabetes epidemic is associated with significant personal and socio-economic consequences. Despite attempts to prevent the complications of diabetes, this disease is still the leading cause of blindness, chronic renal insufficiency and non-traumatic amputation. It is important to detect early on an increase in blood sugar and treat it accordingly to reduce costs and to minimize the personal suffering of those affected. As the number of patients with type 2 diabetes mellitus continues to rise, the number of young women with gestational diabetes mellitus (GDM) also increases. This is a disorder og glucose metabolism, which occurs for the first time in pregnancy. The causes for this are manifold. Among other causes, the increasing age of the mothers and weight gain during pregnancy are risk factors for gestational diabetes. Although it has been recommended that women with gestational diabetes should be re-examined after the birth of their child, many women have not. The study is a follow-up study to clarify whether insulin secretion disorder in women with and after GDM is a risk factor for the occurrence of type 2 diabetes mellitus.

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
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Signed and dated informed consent
  • Enrollment is possible during AND after gestation:
  • Baseline visit (pregnancy): gestational week 24+0 till 31+6
  • Postpartum visits: documented occurence of GDM in previous pregnancy

排除标准

  • Age < 18years
  • Diabetes Mellitus Type 1 or Type 2
  • GFR < 60 ml/min/1,73 m2
  • CRP > 1 mg/dl
  • Increased levels of transaminases 2 fold above ULN
  • Preexisting cardiac conditions
  • Weight loss > 10% within 6 months prior to inclusion
  • Psychiatric disorders
  • Chronic alcohol or substance abuse
  • Blood sugar increasing or decreasing drug therapy, e.g. steroids, antidiabetics, insulin
  • only postpartum visits: pregnancy or lactation

结局指标

主要结局

Glucose tolerance during 75 g oral glucose tolerance test

时间窗: Glycemia from start of glucose tolerance test (0 minutes) until the end (120 minutes)

Glucose tolerance, insulin sensitivity and insulin secretion during oral glucose tolerance test

次要结局

  • Glucose tolerance during 75 g oral glucose tolerance test 1, 2, 5, 10 years postpartum(Glycemia from start of glucose tolerance test (0 minutes) until the end (120 minutes))
  • BMI(Once during pregnancy and 1, 2, 5, and 10 years postpartum)
  • Assessment of cognitive abilities in offspring(6 and 10 years postpartum)
  • BIA in offspring(2, 6 and 10 years postpartum)
  • blood sample(6 and 10 years postpartum)
  • Spiroergometry to assess physical fitness(1, 2, 5, and 10 years postpartum)
  • Assessment of cognitive, motoric and language development in offspring(2 years postpartum)
  • Body fat distribution(Once during pregnancy and 1, 2, 5, and 10 years postpartum)
  • BIA (bioimpedance analysis)(Once during pregnancy and 1, 2, 5, and 10 years postpartum)
  • Electrocardiogram(2, 6 and 10 years postpartum)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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