Effects of Oral Androgen Administration on Hyperglycemia-Induced Inflammation in Lean Reproductive-Age Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Nuclear factor kappa B (NFkappaB) activation
研究概览
简要总结
The hypothesis of this study is that DHEA administration to increase male hormone in healthy normal-weight young women to levels present in women with Polycystic Ovary Syndrome will cause an inflammatory response in white blood cells in the fasting state, and in response to glucose ingestion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
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
- •Acceptable health based on interview, medical history, physical examination and lab tests
- •Ability to comply with requirements of the study
- •Ability and willingness to provide signed, witnessed informed consent
- •Between the ages of 18-40 years
- •Body mass index between 18 and 25
- •Normal regular monthly periods
- •No clinical evidence of androgen excess
- •No evidence of polycystic ovaries on ultrasound
排除标准
- •Diabetes mellitus
- •Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious and malignant disease
- •High blood pressure
- •Current or recent (within 30 days prior to study entry) use of any drugs known or suspected to affect reproductive function including oral contraceptives, metformin, gonadotropin releasing hormone agonists, or anti-androgens (spironolactone, flutamide, etc.)
- •Use of medications that have an adverse drug interaction with DHEA therapy including antipsychotics, phenothiazines, lithium, selective serotonin reuptake inhibitors, triazolam, estrogen or testosterone formulations
- •Known hypersensitivity to DHEA
- •Two first-degree relatives with breast cancer or ovarian cancer
- •Documented or suspected history of recent (within 1 year) illicit drug abuse or alcoholism
- •Tobacco smoking
- •Ingestion of any investigational drugs within 4 weeks prior to study onset
- •Pregnancy or lactation (less than or equal to 6 weeks postpartum)
研究组 & 干预措施
Placebo Group
Oral administration of an identical capsule containing placebo for 5 days.
干预措施: Placebo (Other)
DHEA Group
Oral administration of a capsule containing 130 mg of dehydroepiandrosterone (DHEA) for 5 days.
干预措施: Dehydroepiandrosterone (DHEA) (Dietary Supplement)
结局指标
主要结局
Nuclear factor kappa B (NFkappaB) activation
时间窗: 0 and 2 hours after glucose ingestion
White blood cell NFkappaB activation will be assessed in response to glucose ingestion before and after 5 days of DHEA or placebo administration.
次要结局
- Insulin sensitivity(0 and 5 days after DHEA or placebo)
研究者
Frank Gonzalez
Study Principal Investigator
Mayo Clinic