search
Back to results

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

Primary Purpose

Obesity

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Celebrex
Sponsored by
Rockefeller University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring Obesity, Post-menopausal

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • The Rockefeller University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Celebrex

Arm Description

10 days treatment with Celebrex to evaluate reduction of PGE-M in urine

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 10, 2013
Last Updated
January 28, 2021
Sponsor
Rockefeller University
search

1. Study Identification

Unique Protocol Identification Number
NCT01901679
Brief Title
Celecoxib Inhibition of Aromatase Expression and Inflammation in Adipose Tissue of Obese Postmenopausal Women
Official Title
A Pilot Study: Celecoxib Inhibition of Aromatase Expression and Inflammation in Adipose Tissue of Obese Postmenopausal Women
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rockefeller University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Post-menopausal

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Celebrex
Arm Type
Experimental
Arm Description
10 days treatment with Celebrex to evaluate reduction of PGE-M in urine
Intervention Type
Drug
Intervention Name(s)
Celebrex
Other Intervention Name(s)
Celecoxib
Intervention Description
200 mg PO BID
Primary Outcome Measure Information:
Title
To Determine Whether Oral Administration of Celebrex to Obese Women Will Reduce the PGE-M in Urine
Description
Study endpoint is a reduction in PGE-M in urine after treatment with celebrex
Time Frame
10 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Holt, MD
Organizational Affiliation
Rockefeller University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Rockefeller University
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs