Psoriasis VulgarisNCT04242082
Glucose Trnsporter and PEDF in Psoriasis
An observational study of Psoriasis Vulgaris, run by Assiut University.
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. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- GLUT 1 gene expression
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 31 Jul 2020to 1 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
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)
Who may be able to join
- Patients with psoriasis vulgaris Patients with psoriasis vulgaris and type 2 diabetes
Who cannot join
- Factors affect GLUT 1 expression As: tumors either benign or malignant cause increase GLUT 1 expression
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Role of Glucose Transporter (GLUT) Genes Expression in Patients With Psoriasis
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.
Read more
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 .
- Conditions
- Psoriasis Vulgaris
- Being tested
- GLUT 1 gene expression
- Keywords
- GLUT 1, PEDF, Psoriasis Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLUT 1 gene expressionDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| patients with psoriasis vulgaris only | Not described Receives: Diagnostic Test: GLUT 1 gene expression | |
| patients with psoriasis vulgaris and type 2 diabetes mellitus | Not described Receives: Diagnostic Test: GLUT 1 gene expression | |
| healthy control | Not described Receives: Diagnostic Test: GLUT 1 gene expression |
What is being measured
The primary outcome is the main question the study is designed to answer.
GLUT1 expression in psoriatic patients with or without type 2 diabetes.
assessing fold changes of GLUT1 expression in blood samples using real time PCR.
Measured: through study completion, an average of 2 year
GLUT1 expression in keratinocyte before and after treatment with pigment epithelium derived factor (PEDF)
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start31 Jul 2020 (estimated)
- Primary completion31 Jul 2020 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SSElkady, Assiut University
- Investigators
- Naglaa K Idriss, asst. prof, Study director, Assiut UniversityAyaat ِA Sayed, asst. prof, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04242082
- Sponsor's protocol ID
- PGLUTPEDF
- Status last verified
- May 2020
- First submitted
- 21 Jan 2020
- Last updated
- 8 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 23392136Sondermann W, Djeudeu Deudjui DA, Korber 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. doi: 10.1111/jdv.16029. Epub 2019 Dec 3.
PubMed 31797464Sarac 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.
PubMed 28058392Holm 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.
PubMed 30697518Granata 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.
PubMed 27639922Hagg D, Sundstrom 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):583-590. doi: 10.1007/s40257-017-0274-0.
PubMed 28342016Li 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. eCollection 2019.
PubMed 31819584Matsuura 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. Epub 2017 Mar 27.
PubMed 28431948Lee 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.
PubMed 26499368Shaker 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.
PubMed 22361809Gaither 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. doi: 10.1210/jcem.84.2.5438.
PubMed 10022440Calado SM, Alves LS, Simao 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.
PubMed 27440994Abe 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):183-91. doi: 10.1016/j.jdermsci.2009.12.010. Epub 2010 Jan 8.
PubMed 20060688Pyla 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.
PubMed 23302780Shurman 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. doi: 10.1167/iovs.04-1364.
PubMed 15914609
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Glucose Transporter (GLUT) Genes Expression in Patients With Psoriasis
- ClinicalTrials.gov ID
- NCT04242082
- Acronym / sponsor ID
- PGLUTPEDF
- Conditions
- Psoriasis Vulgaris
- Keywords
- GLUT 1, PEDF, Psoriasis Vulgaris
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 31 Jul 2020 (estimated)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patients with psoriasis vulgaris only | – | Diagnostic Test: GLUT 1 gene expression |
| patients with psoriasis vulgaris and type 2 diabetes mellitus | – | Diagnostic Test: GLUT 1 gene expression |
| healthy control | – | Diagnostic Test: GLUT 1 gene expression |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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)
Key inclusion criteria (1 listed)
- Patients with psoriasis vulgaris Patients with psoriasis vulgaris and type 2 diabetes
Key exclusion criteria (1 listed)
- Factors affect GLUT 1 expression As: tumors either benign or malignant cause increase GLUT 1 expression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLUT 1 gene expressionGLUT 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. | Diagnostic test | healthy control, patients with psoriasis vulgaris and type 2 diabetes mellitus, patients with psoriasis vulgaris only |
Primary outcome
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.
GLUT1 expression in keratinocyte before and after treatment with pigment epithelium derived factor (PEDF)
Time frame: through study completion, an average of 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2020.
- Results publication: PubMed 23392136Abdou 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.
- Results publication: PubMed 31797464Sondermann W, Djeudeu Deudjui DA, Korber 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. doi: 10.1111/jdv.16029. Epub 2019 Dec 3.
- Results publication: PubMed 28058392Sarac 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.
- Results publication: PubMed 30697518Holm 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.
- Results publication: PubMed 27639922Granata 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.
- Results publication: PubMed 28342016Hagg D, Sundstrom 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):583-590. doi: 10.1007/s40257-017-0274-0.
- Results publication: PubMed 31819584Li 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. eCollection 2019.
- Results publication: PubMed 28431948Matsuura 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. Epub 2017 Mar 27.
- Results publication: PubMed 26499368Lee 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.
- Results publication: PubMed 22361809Shaker 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.
- Results publication: PubMed 10022440Gaither 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. doi: 10.1210/jcem.84.2.5438.
- Results publication: PubMed 27440994Calado SM, Alves LS, Simao 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naglaa K Idriss, asst. prof study director
Assiut University
Ayaat ِA Sayed, asst. prof study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis Vulgaris, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sherouk S Elkady, demonstrator (+002 01066090960, sheroukelkady@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GLUT1 expression in psoriatic patients with or without type 2 diabetes. (time frame: through study completion, an average of 2 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04242082, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2020.