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临床试验/NCT01665716
NCT01665716已完成不适用

Ovarian Ageing in Type 1 Diabetes Mellitus: the Role of Vascular Factors

UMC Utrecht1 个研究点 分布在 1 个国家目标入组 290 人开始时间: 2011年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
UMC Utrecht
入组人数
290
试验地点
1
主要终点
OVADIA 1: serum AMH level

研究概览

简要总结

In healthy women, early menopause is an event that is associated with the exacerbation of several risk factors of cardiovascular and skeletal disease. The occurrence of an early menopause may have even greater impact in women with type 1 diabetes mellitus (DM-1). A small number of studies has demonstrated that DM-1 patients experience cycle irregularity and menopause at a younger age compared to controls. In addition, initial studies have suggested that also in regular cycling DM-1 women a decreased ovarian reserve status for age is present. The explanation for this early decay in ovarian reserve in DM-1 patients remains unknown. Next to auto immunity, vascular factors may be possible contributors to accelerated ovarian ageing in DM-1 patients.

Confirmation of more accelerated ovarian ageing in DM-1 women is urgently needed in view of the added risk factors outlined above. Also, the mechanisms behind the advanced ovarian ageing, with focus on vascular factors, may shed new light on our understanding of the ovarian ageing process per se.

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

入选标准

  • Patients: females diagnosed with type 1 diabetes mellitus
  • Controls: healthy age-matched female controls

排除标准

  • Induced menopause: surgical (premenopausal hysterectomy and/or bilateral ovariectomy), chemo- or radiation therapy, ovarian surgery and irregular menstrual cycles.

结局指标

主要结局

OVADIA 1: serum AMH level

时间窗: Blood withdrawel once at screening

OVADIA 2: Age at menopause

时间窗: Assesed once in questionnaire

次要结局

未报告次要终点

研究者

发起方
UMC Utrecht
申办方类型
Other
责任方
Principal Investigator
主要研究者

Frank JM Broekmans

Prof. Dr. F. J. M. Broekmans

UMC Utrecht

研究点 (1)

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