NCT03493984撤回不适用
A Preliminary Clinical Trial Investigating the Ability of Plant Exosomes to Mitigate Insulin Resistance and Chronic Inflammation in Patients Diagnosed With Polycystic Ovary Syndrome (PCOS)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in glucose tolerance as measured by a glucose tolerance test
研究概览
简要总结
The purpose of this study is to see if substances contained in ginger or aloe plants, called exosomes, will treat and improve the condition polycystic ovary syndrome
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18-40 year
- •Patients must have a confirmed diagnosis of PCOS according to the Rotterdam Criteria. At least 2 of the following 3 characteristics must be present:
- •Oligo-anovulation
- •Clinical and/or biochemical signs of androgen excess and
- •Polycystic ovarian morphology (PCOM) (defined by an increased number of small antral follicles [≥12 follicles that were <10 mm in diameter] or an increased individual ovarian volume [>10 cm3] in 1 or both ovaries. Disorders mimicking PCOS must also be excluded, including thyroid dysfunction, hyperprolactinemia, late-onset congenital adrenal hyperplasia, and ovarian or adrenal androgen-producing tumors.
- •Of all subjects screened patients must be informed of the investigational nature of this study and give written informed consent in accordance with institutional and federal guidelines.
- •Ability to understand and willingness to sign a written informed consent document.
- •Absence of life limiting medical conditions
排除标准
- •• Pregnancy
- •Known HIV
- •Patients receiving immunosuppressive drugs
- •Patients taking confounding medications such as sex steroids, infertility medications or insulin sensitizers or any medication deemed to alter glucose and/or insulin levels
- •Active malignancy in the last 5 years
- •Patients receiving any other investigational agent(s)
- •Ginger and/or aloe allergy
结局指标
主要结局
Change in glucose tolerance as measured by a glucose tolerance test
时间窗: Baseline, twelve weeks.
A glucose challenge test will be administered after initially obtaining a fasting serum glucose(baseline), then administering a 75 gram glucose load orally, then a serum glucose will be obtained 2 hours later. Serum glucose is measured in mg/dL.
次要结局
- Inflammatory marker Foxp3(Baseline, twelve weeks)
- Inflammatory marker interleukin 10 (IL-10)(Baseline, twelve weeks)
- Inflammatory marker interleukin 1b (IL-1b)(Baseline, twelve weeks)
- Change in serum insulin levels during a glucose tolerance test(Baseline, twelve weeks)
- Stool sample(Baseline, twelve weeks)
- Inflammatory marker cluster of differentiation 4 (CD4)(Baseline, twelve weeks)
- Inflammatory marker cluster of differentiation 11b (CD11b)(Baseline, twelve weeks)
- Inflammatory marker F4/80(Baseline, twelve weeks)
- Inflammatory marker cluster of differentiation 33 (CD33)(Baseline, twelve weeks)
- Inflammatory marker tumor necrosis factor alpha (TNF-a)(Baseline, twelve weeks)
- Sex hormone binding globulin(Baseline, twelve weeks)
- Inflammatory marker cluster of differentiation 8 (CD8)(Baseline, twelve weeks)
- Inflammatory marker interleukin 6 (IL-6)(Baseline, twelve weeks)
- Serum Testosterone(Baseline, twelve weeks)
研究者
研究点 (2)
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