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临床试验/NCT01745471
NCT01745471进行中(未招募)不适用

Adipose Tissue Angiogenesis in Polycystic Ovary Syndrome (PCOS)

AdventHealth Translational Research Institute1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2012年12月6日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
36
试验地点
1
主要终点
Difference of angiogenesis capacity in abdominal and gluteal adipose tissue

研究概览

简要总结

The purpose of this study is to collect data to help understand why some women develop Polycystic Ovary Syndrome (PCOS) associated with decreased lower-body fat.

详细描述

Epigenetics may represent a new regulator mechanism explaining gluteal vs. abdominal fat differences.

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
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age > 20 and < 40
  • Weight stable (change of less than 3 kg in the last 8 weeks)
  • BMI < 40 kg/m2 or > 27 kg/m2
  • Supplemental inclusion criteria for PCOS women:
  • NIH criteria - confirmed by subjects' medical records.

排除标准

  • Women who are pregnant or lactating (breast feeding)
  • Post-menopausal women
  • Women with hysterectomy
  • Diagnosed with diabetes, or have a fasting blood sugar > 126 mg/dL.
  • Untreated or symptomatic thyroid disease.
  • Impaired kidney or liver function, as evidenced by your blood work
  • Hypertension/ high blood pressure or are taking blood pressure medications
  • Use of oral contraceptives or hormone replacement therapy.
  • History of drug or alcohol abuse (> 3 drinks per day) in the last 5 years, or psychiatric disease prohibiting adherence to study protocol.
  • History of cancer within the last 5 years.
  • History of organ transplant.
  • History of HIV, active Hepatitis B or C, or Tuberculosis.
  • History of heart attack/ myocardial infarction.
  • Presence of clinically significant abnormalities on EKG.
  • Current smokers (smoking within the past 3 months)
  • Use of any medications known to influence glucose, fat and/or energy metabolism within the last 3 months (e.g., growth hormone therapy, glucocorticoids [steroids], etc.). Metformin for women with PCOS is allowed.

结局指标

主要结局

Difference of angiogenesis capacity in abdominal and gluteal adipose tissue

时间窗: Day 7

The angiogenesis capacity of each adipose tissue depot will be determine by an in vitro angiogenesis test.

次要结局

  • Presence of biomarkers in abdominal and gluteal adipose tissue in obese and PCOS women(Day 7)
  • Difference in oxygen content of abdominal and gluteal adipose tissue(Day 6)

研究者

发起方
AdventHealth Translational Research Institute
申办方类型
Other
责任方
Sponsor

研究点 (1)

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