Status:
COMPLETED
Celecoxib Inhibition of Aromatase Expression and Inflammation in Adipose Tissue of Obese Postmenopausal Women
Lead Sponsor:
Rockefeller University
Conditions:
Obesity
Eligibility:
FEMALE
40-70 years
Phase:
EARLY_PHASE1
Brief Summary
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 ri...
Detailed Description
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. V...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01901679
Start Date
July 1 2013
End Date
August 1 2014
Last Update
February 1 2021
Active Locations (1)
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1
The Rockefeller University
New York, New York, United States, 10065