Glucose Profiles in Women With Polycystic Ovary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Time in range (TIR)
研究概览
简要总结
Polycystic ovary syndrome is a very common condition that is associated with metabolic complications. Patients with polycystic ovary syndrome exhibit insulin resistance and are at greater risk to develop type 2 diabetes. This syndrome is heterogeneous, classified according to 4 phenotypes (A-D). It seems that certain phenotypes are less exposed to insulin resistance and metabolic complications. However, only a few studies have evaluated the glucose profile according to phenotype. New technologies now make it possible to monitor glucose levels continuously. The aim of this project is to evaluate glucose profile parameters using continuous glucose monitoring, and to compare these profiles according to different PCOS phenotypes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years at inclusion criteria
- •Patient with polycystic ovary syndrome, defined by the presence of at least 2/3 irregular menstrual cycles, clinical or biological hyperandrogenism, polycystic ovary morphology (pelvic ultrasound) or elevated AMH levels, after the exclusion of other disorders.
- •Agreed to carry the FSL pro
- •Signed informed consent
排除标准
- •Pregnancy, breast-feeding
- •Differential diagnoses: hyperprolactinemia, dysthyroidism, Cushing's syndrome, congenital adrenal hyperplasia, virilizing tumor (ovarian or adrenal), intake of exogenous androgens
- •Pre-existing diabetes
- •Patient treated within 3 months prior to inclusion/data collection with estrogen-progestin contraception, progestin contraception, antidiabetic drugs, inositol, antiandrogen
研究组 & 干预措施
Phenotype A
oligomenorrhoea or amenorrhoea + hyperandrogenism + polycystic ovary morphology or elevated AMH levels
干预措施: sensor (Device)
Phenotype A
oligomenorrhoea or amenorrhoea + hyperandrogenism + polycystic ovary morphology or elevated AMH levels
干预措施: Age reader (Device)
Phenotype B
hyperandrogenism + oligomenorrhoea or amenorrhoea
干预措施: sensor (Device)
Phenotype B
hyperandrogenism + oligomenorrhoea or amenorrhoea
干预措施: Age reader (Device)
Phenotype C
hyperandrogenism + polycystic ovary morphology or elevated AMH levels
干预措施: sensor (Device)
Phenotype C
hyperandrogenism + polycystic ovary morphology or elevated AMH levels
干预措施: Age reader (Device)
Phenotype D
oligomenorrhoea or amenorrhoea + polycystic ovary morphology or elevated AMH levels
干预措施: sensor (Device)
Phenotype D
oligomenorrhoea or amenorrhoea + polycystic ovary morphology or elevated AMH levels
干预措施: Age reader (Device)
结局指标
主要结局
Time in range (TIR)
时间窗: 14 days
Time in range (TIR) variation between 4 groups
次要结局
- Average glycaemia(14 days)
- Glycemic variability(14 days)
- Presence of hypoglycaemia(14 days)
- Time in tight range(14 days)
- HbA1C(14 days)
- Time above the range(14 days)
- Oral glucose tolerance test data(14 days)
- Evaluation of glycation end products by AGE reader(14 days)
- Assessment of insulin resistance(14 days)