Treating Polycystic Ovarian Syndrome (PCOS) With Digital Intervention vs. Metformin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Homeostasis model assessment of insulin resistance
研究概览
简要总结
With the change in environment and lifestyle, and the improvement of people's understanding of PCOS, the incidence of PCOS is increasing worldwide. According to statistics, the prevalence of PCOS in premenopausal women is as high as 5-20%. Lifestyle interventions are the main treatment option for patients with PCOS. In addition, research has shown that digital therapy can effectively improve behavior changes in diet, exercise, and medication adherence, predict disease progression, reduce the frequency of disease-related symptoms, and promote effective disease management. This study aimed to investigate the efficacy of digital intervention versus traditional metformin monotherapy in patients with PCOS.
详细描述
This study developed a mini-program that combined diet, exercise, sleep, and mood interventions for PCOS women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female aged 18- 45; Meet Rotterdam criteria; Insulin Resistance
排除标准
- •Women who are pregnant or have a pregnancy plan within six months; Congenital adrenocortical hyperplasia; Hyperprolactinemia; Hyperthyroidism or hypothyroidism; Abnormal liver function (≥ 3 times the upper limit of the normal range); Abnormal renal function (GFR<60ml/min/1.73m2); Adrenal or ovarian tumors secreting androgens; Used contraceptives, metformin, pioglitazone, and antidepressant medication in the last 3 months.
研究组 & 干预措施
Digital Intervention
A mini program-based digital intervention.
干预措施: Digital Intervention (Behavioral)
Metformin
Traditional metformin monotherapy.
干预措施: Metformin (Drug)
结局指标
主要结局
Homeostasis model assessment of insulin resistance
时间窗: 3 months
insulin resistance index
次要结局
- Androstenedione(3 months)
- free testosterone(3 months)
- Pittsburgh Sleep Quality Index (PSQI)(3 months)
- fasting glucose(3 months)
- fasting insulin(3 months)
- total testosterone(3 months)
- Total cholesterol(3 months)
- menstrual frequency(3 months)
- Triglycerides(3 months)
- HDL-c(3 months)
- LDL-c(3 months)
- Anthropometry(3 months)
- Sex hormone-binding globulin(3 months)
- Dehydroepiandrosterone(3 months)
- International Physical Activity Questionnaire (IPAQ)(3 months)
- Hospital Anxiety and Depression Scale (HADS)(3 months)
- Three-Factor Eating Questionnaire (TFEQ-R21)(3 months)
研究者
Zhang Manna
Director, Principal Investigator, Clinical Professor
Shanghai 10th People's Hospital