Obesity
Conditions
Keywords
Obesity, Post-menopausal
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 risk of developing breast cancer and lead to a poor outcome of the disease.
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. 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.
Interventions
DRUGCelebrex
200 mg PO BID
Sponsors
Rockefeller University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Determine Whether Oral Administration of Celebrex to Obese Women Will Reduce the PGE-M in Urine | 10 days | Study endpoint is a reduction in PGE-M in urine after treatment with celebrex |
Countries
United States
Participant flow
Recruitment details
Recruitment was conducted during 2 outpatient visits at Rockefeller University Hospital outpatient clinic. Recruitment of subjects began on 6/10/13 and was completed on 6/30/14.
Pre-assignment details
All participants were screened for their usual dietary intake and instructed to continue to follow their usual diet during weeks prior to hospital admission and thoughout the entire study. . First group underwent 3 day run-in period inpatient, the second group underwent 14 day run-in period prior to starting Celecoxib 200mg po BID X 10 days.
Participants by arm
| Arm | Count |
|---|---|
| 3 Day run-in Period After 3 day run-in period, participants underwent baseline testing then started 10 days of Celecoxib 200mg po BID. Follow-up blood and stool collection was performed as outpatients 7-10 days after discharge. | 5 |
| 14 Day run-in Period After 14 day run-in period, participants underwent baseline testing then started 10 days of Celecoxib 200mg po BID. Follow-up blood and stool collection was performed as outpatients 7-10 days after discharge. | 5 |
| Total | 10 |
Baseline characteristics
| Characteristic | 3 Day run-in Period | 14 Day run-in Period | Total |
|---|---|---|---|
| Age, Continuous | 62 years | 56 years | 59 years |
| BMI | 40.2 kg/m^2 | 39.7 kg/m^2 | 40.0 kg/m^2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 1 Participants | 3 Participants |
| Region of Enrollment United States | 5 participants | 5 participants | 10 participants |
| Sex/Gender, Customized Female | 5 participants | 5 participants | 10 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 2 / 5 | 4 / 5 |
| serious Total, serious adverse events | 1 / 5 | 0 / 5 |
Outcome results
Primary
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
Time frame: 10 days
Population: These samples were collected but not analyzed due to technical reasons. Investigator has retired and access to results was not available for this outcome. Best efforts were made to obtain the data; however, they were unsuccessful.