Celecoxib Inhibition of Aromatase Expression and Inflammation in Adipose Tissue of Obese Postmenopausal Women
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 40 - 70 |
| Updated: | 11/8/2014 |
| Start Date: | July 2013 |
| End Date: | July 2015 |
A Pilot Study: Celecoxib Inhibition of Aromatase Expression and Inflammation in Adipose Tissue of Obese Postmenopausal Women
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.
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.
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.
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.
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.
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