Celecoxib Inhibition of Aromatase Expression and Inflammation in Adipose Tissue of Obese Postmenopausal Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Pilot Study: Celecoxib Inhibition of Aromatase Expression and Inflammation in Adipose Tissue of Obese Postmenopausal Women

Conditions
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Obesity

Intervention / Treatment
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* Drug: Celebrex


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Celebrex<br>10 days treatment with Celebrex to evaluate reduction of PGE-M in urine | Drug: Celebrex<br>* 200 mg PO BID<br>* Other names: Celecoxib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Determine Whether Oral Administration of Celebrex to Obese Women Will Reduce the PGE-M in Urine | Study endpoint is a reduction in PGE-M in urine after treatment with celebrex | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Post-menopausal