Evaluation of HbA1c Levels and Ovarian Reserve in Patients With Type 1 Diabetes Diagnosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Antral follicle count (AFC)
研究概览
简要总结
The human ovary is the target of an autoimmune attack, usually in organ or non-specific autoimmune disorders. Serum anti-Müllerian hormone (AMH) levels decrease early in menopause and menopause is seen in women with type 1 diabetes mellitus (DM1) at a young age. DM1 is aimed to show DM1 relationship with ovarian reserve based on the assumption that it will have lower AMH levels than controls, secondary to bad glycemic control and autoimmune attack in women.
详细描述
The study was designed prospectively. Ovarian functions in healthy volunteer women and patients who use DM1 diagnosed between 18-40 years old will be examined. Gonadotropin and AMH levels will be measured in follicular phase. To calculate the number of antral follicles (AFC) and ovarian volume, ultrasound will be looked at. Fasting and satiety blood glucose, HbA1c and C-peptide levels will be evaluated.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female patients between 18 and 40 years of age who had consent and had gynecological examination in our polyclinic;
- •study group for patients with type 1 diabetes mellitus healthy volunteers control group
排除标准
- •Other endocrine and / or autoimmune disorders, polycystic ovary syndrome (PCOS) and
- •previous surgery, which may reduce ovarian reserves;
- •medical and / or radiotherapy
结局指标
主要结局
Antral follicle count (AFC)
时间窗: On the 3rd day of the menstrual cycle
AFC was calculated by counting 2-10 mm diameter follicles in both ovaries with a standard systematic approach.Recorded as a number.
HbA1c
时间窗: On the 3rd day of the menstrual cycle
HBA1C concentrations were measured by taking venous blood samples in the early morning hours. HBA1C (mmol / mol) saved as.
Anti müllerian hormone (AMH)
时间窗: On the 3rd day of the menstrual cycle
AMH concentrations were measured by an enzymatically enhanced bilaterally immunoassay. AMH (pmol / l) saved as.
次要结局
未报告次要终点
研究者
Pınar Kadirogulları
principal investigator, M.D, Department of Obstetrics and GynecologyR
Kanuni Sultan Suleyman Training and Research Hospital