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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04242082
Other study ID # PGLUTPEDF
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 31, 2020
Est. completion date March 1, 2021

Study information

Verified date May 2020
Source Assiut University
Contact Sherouk S Elkady, demonstrator
Phone +002 01066090960
Email sheroukelkady@med.aun.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 75
Est. completion date March 1, 2021
Est. primary completion date July 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (15)

Abdou AG, Maraee AH, Eltahmoudy M, El-Aziz RA. Immunohistochemical expression of GLUT-1 and Ki-67 in chronic plaque psoriasis. Am J Dermatopathol. 2013 Oct;35(7):731-7. doi: 10.1097/DAD.0b013e3182819da6. — View Citation

Abe R, Yamagishi S, Fujita Y, Hoshina D, Sasaki M, Nakamura K, Matsui T, Shimizu T, Bucala R, Shimizu H. Topical application of anti-angiogenic peptides based on pigment epithelium-derived factor can improve psoriasis. J Dermatol Sci. 2010 Mar;57(3):183-9 — View Citation

Calado SM, Alves LS, Simão S, Silva GA. GLUT1 activity contributes to the impairment of PEDF secretion by the RPE. Mol Vis. 2016 Jul 14;22:761-70. eCollection 2016. — View Citation

Gaither K, Quraishi AN, Illsley NP. Diabetes alters the expression and activity of the human placental GLUT1 glucose transporter. J Clin Endocrinol Metab. 1999 Feb;84(2):695-701. — View Citation

Granata M, Skarmoutsou E, Trovato C, Rossi GA, Mazzarino MC, D'Amico F. Obesity, Type 1 Diabetes, and Psoriasis: An Autoimmune Triple Flip. Pathobiology. 2017;84(2):71-79. doi: 10.1159/000447777. Epub 2016 Sep 17. Review. — View Citation

Hägg D, Sundström A, Eriksson M, Schmitt-Egenolf M. Severity of Psoriasis Differs Between Men and Women: A Study of the Clinical Outcome Measure Psoriasis Area and Severity Index (PASI) in 5438 Swedish Register Patients. Am J Clin Dermatol. 2017 Aug;18(4) — View Citation

Holm JG, Thomsen SF. Type 2 diabetes and psoriasis: links and risks. Psoriasis (Auckl). 2019 Jan 17;9:1-6. doi: 10.2147/PTT.S159163. eCollection 2019. Review. — View Citation

Lee JH, Kim JS, Park SY, Lee YJ. Resveratrol induces human keratinocyte damage via the activation of class III histone deacetylase, Sirt1. Oncol Rep. 2016 Jan;35(1):524-9. doi: 10.3892/or.2015.4332. Epub 2015 Oct 16. — View Citation

Li Y, Song Y, Zhu L, Wang X, Yang B, Lu P, Chen Q, Bin L, Deng L. Interferon Kappa Is Up-Regulated in Psoriasis and It Up-Regulates Psoriasis-Associated Cytokines in vivo. Clin Cosmet Investig Dermatol. 2019 Nov 29;12:865-873. doi: 10.2147/CCID.S218243. e — View Citation

Matsuura T, Sato M, Nagai K, Sato T, Arito M, Omoteyama K, Suematsu N, Okamoto K, Kato T, Soma Y, Kurokawa MS. Serum peptides as putative modulators of inflammation in psoriasis. J Dermatol Sci. 2017 Jul;87(1):36-49. doi: 10.1016/j.jdermsci.2017.03.014. E — View Citation

Pyla R, Poulose N, Jun JY, Segar L. Expression of conventional and novel glucose transporters, GLUT1, -9, -10, and -12, in vascular smooth muscle cells. Am J Physiol Cell Physiol. 2013 Mar;304(6):C574-89. doi: 10.1152/ajpcell.00275.2012. Epub 2013 Jan 9. — View Citation

Sarac G, Koca TT, Baglan T. A brief summary of clinical types of psoriasis. North Clin Istanb. 2016 Jun 14;3(1):79-82. doi: 10.14744/nci.2016.16023. eCollection 2016. Review. — View Citation

Shaker O, Abdel-Halim M. Connexin 26 in psoriatic skin before and after two conventional therapeutic modalities: methotrexate and PUVA. Eur J Dermatol. 2012 Mar-Apr;22(2):218-24. doi: 10.1684/ejd.2012.1649. — View Citation

Shurman DL, Glazewski L, Gumpert A, Zieske JD, Richard G. In vivo and in vitro expression of connexins in the human corneal epithelium. Invest Ophthalmol Vis Sci. 2005 Jun;46(6):1957-65. — View Citation

Sondermann W, Djeudeu Deudjui DA, Körber A, Slomiany U, Brinker TJ, Erbel R, Moebus S. Psoriasis, cardiovascular risk factors and metabolic disorders: sex-specific findings of a population-based study. J Eur Acad Dermatol Venereol. 2020 Apr;34(4):779-786. — View Citation

* Note: There are 15 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary GLUT1 expression in psoriatic patients with or without type 2 diabetes. assessing fold changes of GLUT1 expression in blood samples using real time PCR. through study completion, an average of 2 year
Primary GLUT1 expression in keratinocyte before and after treatment with pigment epithelium derived factor (PEDF) through study completion, an average of 2 year
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