Menstrual Cycle Changes in Adolescent Girls With Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 110
- 主要终点
- Number of participants with menstrual irregularities
研究概览
简要总结
To assess menstraul cycle changes in adolescent girls with diabetes and to find out the various risk factors
详细描述
Type 1 diabetes mellitus (T1DM) is the result of autoimmunity mediated destruction of pancreatic beta cells, ultimately causing insulin deficiency and, consequently, hyperglycemia .
Typically the diagnosis of T1DM is made in childhood or adolescence,but about 40% of affected individuals are diagnosed in adulthood.
Hyperglycemia-related complications can contribute to impairment of endocrine axes, such as the hypothalamic pituitary gonadal (HPG) axis .
Historically, before the introduction of insulin replacement therapy, prepubertal girls wh developed T1DM rarely showed normal sexual development, exhibiting primary amenorrhea .
Although the introduction of insulin drastically changed the natural history of T1DM, allowing restoration of the HPG physiology, menarche delay remained as a typical sign in girls with T1DM .
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 10 Years 至 20 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Girls with diabetes diagnosed based on ADA guidelines Who reatched menarche of at least 1year duration [14]]
- •Another comparable number of age matched non_diabetic girls will be included as controls.
- •3/Female adolescents aged 10-18 years
排除标准
- •Girls Known thyroid disease or other endocrine disorders affecting menstruation
- •Girls taking medications that may affect menstrual cycles like Use of hormonal therapy (e.g., oral contraceptive pills) within the last 6 months
- •Menstraul irregularitis prior to diagnosis of diabetes
结局指标
主要结局
Number of participants with menstrual irregularities
时间窗: 12 months (from enrollment)
Menstrual cycle characteristics (cycle length, frequency, and regularity) will be documented using a structured menstrual diary and standardized questionnaire. Menstrual irregularity will be defined as the presence of oligomenorrhea (cycle length \> 35 days), amenorrhea (≥ 3 months without menstruation), or polymenorrhea (cycle length \< 21 days). Data will be summarized as the number and percentage of participants meeting any of these criteria.
次要结局
- Association of menstrual irregularities with HbA1c and BMI(12 months (from enrollment))
研究者
Zeinab Megahed Mohammed Shelgamy
Principal Investigator
Assiut University