Clinical Study of PET/CT and Association With Metabolic Syndrome/Depressive Symptoms in Psoriasis

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Pusan National University Hospital
Sponsor:
Information provided by (Responsible Party):
Pusan National University Hospital
ClinicalTrials.gov Identifier:
NCT01661127
First received: August 7, 2012
Last updated: December 5, 2012
Last verified: December 2012
  Purpose

Psoriasis is associated with increases in markers of inflammation in the skin and blood and increasingly is thought to be a systemic inflammatory disease and risk factor for incident diabetes mellitus, myocardial infarction, stroke, and premature cardiovascular death. Furthermore, it is important for clinicians to be aware that psoriasis can have a substantial emotional impact on an individual, which is not necessarily related to the extent of skin disease.

FDG-PET/CT represents an innovative approach to studying systemic inflammation in a manner that is sensitive, quantifiable, and anatomically localizable. Also, recent study show that chronic disease such as end stage renal disease with depressive symptoms have decreased cerebral glucose metabolism in several brain areas in F-18-FDG PET/CT. So this protocol was designed to evaluate usefulness of PET/CT to detect systemic inflammation and abnormality of cerebral glucose metabolism and association with metabolic syndrome/major depressive symptoms in patients with psoriasis.


Condition
Psoriasis
Metabolic Syndrome
Depression

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Phase 0 Clinical Study of PET/CT and Association With Metabolic Syndrome/Depressive Symptoms in Psoriasis

Resource links provided by NLM:


Further study details as provided by Pusan National University Hospital:

Primary Outcome Measures:
  • Beck depression inventory scoring and Korean Hamilton depression scale scoring [ Time Frame: Day 0 and 28 weeks later ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Brain glucose uptake using PET/CT [ Time Frame: Day 0 and 28 weeks later ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples Without DNA

Peripheral blood and 18-F-FDG PET/CT images


Estimated Enrollment: 10
Study Start Date: June 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Detailed Description:

10 Patients with psoriasis

  1. Evaluate PASI score
  2. Evaluate comorbidity with metabolic syndrome

    • Body mass index(BMI)
    • Checking blood pressure
    • Checking blood sugar
    • Smoking and drinking history
    • Checking blood cholesterol level
    • Risk factors of cardiovascular disease
  3. PET/CT for measuring the extent and site of psoriasis with inflammation
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients of diagnosed with psoriasis in Pusan National University Hospital

Criteria

Inclusion Criteria:

  • Histological diagnosis of plaque type psoriasis
  • at least 18 years old

Exclusion Criteria:

  • those who cannot understand questionnaire
  • those who take antidepressant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01661127

Contacts
Contact: Byung-Soo Kim, Ph D. 82-51-240-7338 dockbs@pusan.ac.kr

Locations
Korea, Republic of
Department of dermatology, Pusan National University Hospital Recruiting
Busan, Korea, Republic of
Contact: Byung-Soo Kim, Ph D.    82-51-240-7338    dockbs@pusan.ac.kr   
Sponsors and Collaborators
Pusan National University Hospital
Investigators
Study Chair: Byung-Soo Kim, Ph D. Pusan National University Hospital
  More Information

No publications provided

Responsible Party: Pusan National University Hospital
ClinicalTrials.gov Identifier: NCT01661127     History of Changes
Other Study ID Numbers: PNUHDM-psoriasis
Study First Received: August 7, 2012
Last Updated: December 5, 2012
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Depression
Depressive Disorder
Psoriasis
Metabolic Syndrome X
Behavioral Symptoms
Mood Disorders
Mental Disorders
Skin Diseases, Papulosquamous
Skin Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 27, 2014