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Glucose Trnsporter and PEDF in Psoriasis

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04242082
Recruitment Status : Not yet recruiting
First Posted : January 27, 2020
Last Update Posted : May 8, 2020
Sponsor:
Information provided by (Responsible Party):
SSElkady, Assiut University

Brief Summary:

Psoriasis is a chronic relapsing cutaneous immune mediated inflammatory disease(IMID). In which there are skin lesions characterized by erythema, thickness and scale formation with different size from a pinhead to 20 cm in diameter. Prevalence of psoriasis is 2% to 4% worldwide. Psoriasis occurs at any age with two peaks: between 15-20 years and between 55-60 years. Women are presented with psoriasis at younger age than men ,but with less severity. lesions usually present on knee, elbow, scalp and sacral region this may be attributed to higher traumatic incident .

Psoriasis vulgaris is the most common type, and accounts 90% of cases. Patients with psoriasis vulgaris present with pain, itching and bleeding from skin lesions.

There are many theories for psoriasis pathogenesis: angiogenesis, decrease in apoptosis of keratinocyte, hyperproliferation , alteration of cell to cell adhesion and immune-mediated inflammation.

Patients with immune mediated inflammatory disease (IMID) are susceptible to develop diabetes mellitus, metabolic syndrome, hyperlipidemia, and hypertension.A previous study found that psoriatic patients are more susceptible to type 2 diabetes compared to control.

Glucose transporter type 1(GLUT1) is upregulated in psoriatic patient attributed to angiogenesis and execessive cell proliferation in those patients .Also expression of GLUT 1 is found high with hyperglycemia . A study reported that GLUT 1 density in placenta of women with gestational diabetes was found to be two folds higher than control.

Pigment epithelium derived factor (PEDF) has antiangiogenic effect. Topical application of PEDF on mouse model of psoriatic disease helps in reduction of skin proliferation and angiogenesis.

GLUT 1 overexpression was found to be associated with decrease in PEDF expression in diabetic retinopathy.

In view of that we will compare the level of GLUT 1 gene in psoriatic patients and psoriatic patients with diabetes, as well as healthy control, and detect the effect of PEDF on GLUT 1 expression in vitro using human keratinocytes cell line .


Condition or disease Intervention/treatment
Psoriasis Vulgaris Diagnostic Test: GLUT 1 gene expression

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Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Role of Glucose Transporter (GLUT) Genes Expression in Patients With Psoriasis
Estimated Study Start Date : July 31, 2020
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
patients with psoriasis vulgaris only Diagnostic Test: GLUT 1 gene expression

GLUT 1 gene expression will done on blood samples taken from three groups using real time PCR.

Pigment epithelium derived factor will used on keratinocytes cell line and compare GLUT 1 gene expression before and after treatment.


patients with psoriasis vulgaris and type 2 diabetes mellitus Diagnostic Test: GLUT 1 gene expression

GLUT 1 gene expression will done on blood samples taken from three groups using real time PCR.

Pigment epithelium derived factor will used on keratinocytes cell line and compare GLUT 1 gene expression before and after treatment.


healthy control Diagnostic Test: GLUT 1 gene expression

GLUT 1 gene expression will done on blood samples taken from three groups using real time PCR.

Pigment epithelium derived factor will used on keratinocytes cell line and compare GLUT 1 gene expression before and after treatment.





Primary Outcome Measures :
  1. GLUT1 expression in psoriatic patients with or without type 2 diabetes. [ Time Frame: through study completion, an average of 2 year ]
    assessing fold changes of GLUT1 expression in blood samples using real time PCR.

  2. GLUT1 expression in keratinocyte before and after treatment with pigment epithelium derived factor (PEDF) [ Time Frame: through study completion, an average of 2 year ]

Biospecimen Retention:   Samples With DNA
Blood samples will taken from three groups.Then RNA will be extracted,then used for cDNA formation followed by real time PCR to see fold changes of GLUT1 genes expression.


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

first group (N=25) : Patients with psoriasis vulgaris second group(N=25) :Patients with psoriasis vulgaris and type 2 diabetes third group(N=25) : healthy control

data collection :

  • Sex
  • Age
  • BMI
  • Blood glucose level ,HA1c using high performance liquid chromatography (HPLC)
  • Duration of disease (T2D and psoriasis)
  • Severity of psoriasis by psoriasis area severity index (PASI)
Criteria

Inclusion Criteria:

  • Patients with psoriasis vulgaris Patients with psoriasis vulgaris and type 2 diabetes

Exclusion Criteria:

  • Factors affect GLUT 1 expression As: tumors either benign or malignant cause increase GLUT 1 expression

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): NCT04242082


Contacts
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Contact: Sherouk S Elkady, demonstrator +002 01066090960 sheroukelkady@med.aun.edu.eg

Sponsors and Collaborators
Assiut University
Investigators
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Study Director: Naglaa K Idriss, asst. prof Assiut University
Study Director: Ayaat ِA Sayed, asst. prof Assiut University
Additional Information:
Publications of Results:

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Responsible Party: SSElkady, Demonstrator at Medical Biochemistry department, Assiut University
ClinicalTrials.gov Identifier: NCT04242082    
Other Study ID Numbers: PGLUTPEDF
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by SSElkady, Assiut University:
GLUT 1
PEDF
Psoriasis Vulgaris
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases