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Psoriasis Inflammation and Systemic Co Morbidities

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01170715
First Posted: July 27, 2010
Last Update Posted: January 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Mary Sullivan-Whalen, Rockefeller University
  Purpose

Psoriasis is a chronic relapsing prevalent inflammatory disease affecting 2-4% of the world's population. Severe psoriasis is a disabling disease affecting the physical and emotional well being of patients, and its effect on quality of life is similar to that seen with other major medical diseases such as diabetes, rheumatoid arthritis, and cancer. Lately, it is increasingly being recognized that psoriasis is not merely a skin disease but is probably associated with other co-morbidities such as psoriatic arthritis, Crohn's disease, the metabolic syndrome and cardio-vascular diseases (CVD). The metabolic syndrome is a combination of diabetes mellitus type II (or insulin resistance), hypertension, central obesity, and combined hyperlipidemia (elevated LDL; decreased HDL; elevated triglycerides). As the literature linking psoriasis and the metabolic syndrome expands, also reports of an increased rate of CVD mortality in psoriasis patients accumulates. These data emphasize that metabolic dysregulations are the leading risk factors for occlusive vascular events and early death in patients with severe psoriasis. Progress in understanding the pathogenesis of these apparently diverse diseases has discovered that low-grade systemic inflammation might be the common physiological pathway that may provide the biological plausibility of the associations discovered in the epidemiological studies. Since some of these co-morbidities often become clinically apparent years after the onset of psoriasis we assume that controlling systemic inflammation might prevent or reverse some of these co-morbidities.

Presently there is no study in psoriasis that shows that a "systemic" co-morbidity can be prevented or treated by reversing skin inflammation.


Condition
Psoriasis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Psoriasis Inflammation and Systemic Co-Morbidities: Is it Preventable or Reversible?

Resource links provided by NLM:


Further study details as provided by Mary Sullivan-Whalen, Rockefeller University:

Primary Outcome Measures:
  • To analyze fat using histology and gene expression before during and after treatment. [ Time Frame: Every 3 months for a year ]

Secondary Outcome Measures:
  • To analyze immunological biomarkers of inflammation in the blood using electrochemiluminescence of the MSD systems approach [ Time Frame: Every 3 months for a year ]

Estimated Enrollment: 30
Study Start Date: June 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Moderate to severe psoriasis
Criteria

Inclusion Criteria:

  1. Age > 18years
  2. Psoriasis affecting Body Surface Area (BSA) > 10% after washout
  3. No systemic anti psoriatic therapy < 30days
  4. Features of the metabolic syndrome (At least one of the following) :

Insulin resistance e.g. fasting insulin>9 pmol/L Blood glucose 100-125 mg/dl TG 150-350 mg/dl HDL<40 mg/dl (for females) and HDL<50 mg/dl (for males) BP > 120/85 BMI > 25 5. Plaque type Psoriasis-

Exclusion Criteria:

Overt diabetes (> 135 mg/dL fasting blood glucose on two (2) separate occasions 2. Hypertension as defined as a systolic BP > 140 &/or a diastolic pressure > 90.

Cannot be on more then one (1) antihypertensive medication 3. Currently have any known malignancy or have a history of malignancy in the 5 past years excluding basal cell carcinoma 4. S/P Cardiovascular event such as Myocardial infarction, any open heart surgery, stroke or other vascular occlusive event 5. Current smokers 6. Known allergy to etanercept 7. Positive PPD 8. HIV positive 9. HCV or HBV positive 10. HbA1C >7 11. current use of hypoglycemic medication 12. Current use of a statin 13. Current use of any anticoagulants 14. Current use of any anti-inflammatory medications (except inhaled steroids) 15. History, physical, or laboratory findings suggestive of any other medical or psychological condition that would, in the opinion of the Principal Investigator, make the candidate ineligible for the study. 16.Females of childbearing age who are pregnant or breast-feeding or not using a contraceptive. 17. NYHA Class III and Class IV heart failure

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01170715


Locations
United States, New York
The Rockefeller University
New york, New York, United States, 10065
Sponsors and Collaborators
Rockefeller University
Weill Medical College of Cornell University
Investigators
Principal Investigator: Batya Davidovici, MD The Rockefeller University
  More Information

Additional Information:
Responsible Party: Mary Sullivan-Whalen, Clinical Investigator, Rockefeller University
ClinicalTrials.gov Identifier: NCT01170715     History of Changes
Other Study ID Numbers: BDA0688
First Submitted: July 26, 2010
First Posted: July 27, 2010
Last Update Posted: January 10, 2017
Last Verified: January 2017

Keywords provided by Mary Sullivan-Whalen, Rockefeller University:
Psoriasis
Co morbidities
Inflammation

Additional relevant MeSH terms:
Inflammation
Psoriasis
Pathologic Processes
Skin Diseases, Papulosquamous
Skin Diseases