Glucose Evaluation Through Continuous Glucose Monitors in Polycystic Ovary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Difference between change in hemoglobin A1C
研究概览
简要总结
PCOS is the most common endocrine disorder of reproductive aged women. In addition to menstrual and endocrine abnormalities, PCOS is characterized by insulin resistance and glycemic dysregulation. The pattern of glycemic abnormalities among patients with PCOS may be different than the general population, as evidenced by invasive, time consuming, and costly procedures such as the euglycemic clamp or oral glucose tolerance test. Continuous glucose monitoring (CGM) offers an opportunity to evaluate glycemic status in real world conditions. Furthermore, use of a CGM has been found to improve glycemic status among those with prediabetes and diabetes, but little is known about utility among patients with PCOS. The investigators thus seek to 1) characterize glycemic status using CGM among patients with PCOS and 2) assess the impact of CGM use on metabolic and reproductive health in patients with PCOS.
详细描述
Study synopsis:
Recruitment:
- PCOS participants will be recruited from those who are being seen or have previously been seen at the UCSF multidisciplinary PCOS clinic.
- Non-PCOS participants will be recruited from patients being seen at the UCSF Center for Reproductive Health for other clinical evaluations or research projects.
Study protocol:
Aim 1:
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
- 是
入选标准
- •Aged 18-45
- •Female sex
- •Agree to wear a CGM for 10 days
- •Have access to an apple or android smart phone for CGM monitoring
- •Are able to be characterized as PCOS or non-PCOS using the 2003 Rotterdam criteria for PCOS of 2 or more of the following: 1) biochemical or clinical hyperandrogenism, 2) polycystic ovarian morphology on transvaginal ultrasound, and/or 3) oligo-amenorrhea
- •All of the inclusion criteria for aim 1
- •Meet 2003 Rotterdam criteria for PCOS as above
- •Evidence of baseline glycemic dysregulation including any of the following: 1) elevated fasting glucose (100-125 mg/dL), 2) elevated 2 hour glucose (140-200 mg/dL), 3) elevated fasting insulin (>10 mIU/mL), 4) elevated 2 hour insulin (>40 mIU/mL), 5) elevated Hgba1c (5.7- 6.4)
排除标准
- •For both aims 1 and 2:
- •Use of metformin or other anti-diabetic agents
- •Diagnosis of type I or II diabetes mellitus (including those found to have fasting glucose >126, 2 hour glucose >200, Hgba1c >6.5)
- •Prior or current use of CGM
研究组 & 干预措施
Intervention arm - CGM
Participants randomized to intervention arm will be given standard of care nutrition and exercise counseling to optimize weight, nutrition and glycemic status AND will be asked to wear a DEXCOM CGM for 90 days.
干预措施: DEXCOM Continuous Glucose Monitor (CGM) (Device)
Control arm
Participants randomized to control arm will ONLY be given standard of care nutrition and exercise counseling to optimize weight, nutrition and glycemic status.
结局指标
主要结局
Difference between change in hemoglobin A1C
时间窗: 90 days
Difference between change in hemoglobin A1C for 2 treatment arms from baseline to after 90 days
次要结局
- Difference between change in fasting insulin(90 days)