Ovarian Ageing in Type 1 Diabetes Mellitus: the Role of Vascular Factors
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
- 是
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
Frank JM Broekmans
Prof. Dr. F. J. M. Broekmans
UMC Utrecht
