A Pilot Study: Celecoxib Inhibition of Aromatase Expression and Inflammation in Adipose Tissue of Obese Postmenopausal Women
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- To Determine Whether Oral Administration of Celebrex to Obese Women Will Reduce the PGE-M in Urine
研究概览
简要总结
The study plans to find out whether Celebrex may be potentially useful to decrease inflammation in fat tissues and thereby lower the production of substances such as estrogens that may increase the risk of developing breast cancer and lead to a poor outcome of the disease.
详细描述
This study seeks to examine how effective the celebrex may be in reducing inflammation, crown-like structures in fat tissue, the enzyme aromatase, PGE-M in the urine and estrogen in blood and urine. Volunteer subjects will be expected to stay in the hospital for about 2 weeks taking Celebrex for approximately 10 days while eating a diet similar to what they consumed before coming into the hospital for the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postmenopausal woman defined as: 24 consecutive months without a menstrual period and currently not taking any medication known to induce amenorrhea.
- •Serum estradiol < 20 pg/mL
- •Body Mass Index of 35-50
- •Stable weight defined as (+/- 5 %) of body weight for at least three months
- •40-70 years of age
- •Fluent in English
排除标准
- •Known hypersensitivity to celecoxib or sulfonamides
- •Known peptic ulcer disease
- •Hypertension BP > 150/90 (on 2 occasions after resting)
- •Fasting blood glucose > 165 mg/dL
- •HIV positive
- •Screening creatinine > 2X upper limit of normal
- •Screening LFT results > 2x upper limit of normal
- •Smokers (or stopped < 3 months ago)
- •Framingham risk score > 15
- •Evidence of active coronary disease by history and/or EKG
- •Subjects who consume 25 grams of soy protein/day or more than 45 mg of isoflavones/day, for subjects who consume this amount of soy, they may stop for 14 days prior to admission
- •Currently taking NSAIDS, aspirin, (if > once a week, stopped <30 days ago).
- •Consuming > 3 servings of fish or seafood/week
- •Currently taking fish oil, omega-3 supplements or other herbal supplements that exceed GRAS (Generally Recognized as Safe) levels, (if currently taking fish oil/omega-3 supplements, there must be a 30 day washout period)
- •Current use of anti-coagulants
- •Currently taking any weight control medication
- •Currently taking thioridazine
- •Currently taking lithium
- •Currently taking any estrogen/progesterone hormones including vaginal cream, e-string, or vaginal tablets
- •Currently taking any medication that can alter fat stores as determined by the principal investigator
- •History of Inflammatory Bowel Disease or other chronic inflammatory disorders
- •History of any malignancy other than non-melanoma skin cancer in the past 5 years
- •History of any bleeding disorder
- •History of cardiovascular disease
- •Diagnosis of asthma
- •Any medical, psychological or social condition that, in the opinion of the Investigator, would jeopardize the health or well-being of the participant during any study procedures or the integrity of the data.
研究组 & 干预措施
Celebrex
10 days treatment with Celebrex to evaluate reduction of PGE-M in urine
干预措施: Celebrex (Drug)
结局指标
主要结局
To Determine Whether Oral Administration of Celebrex to Obese Women Will Reduce the PGE-M in Urine
时间窗: 10 days
Study endpoint is a reduction in PGE-M in urine after treatment with celebrex
次要结局
未报告次要终点