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The use of semaglutide in patients with DMT2 and psoriasis contributes to improving the clinical picture of psoriasis and reducing the inflammatory response
After being informed about the study and potential risiks all patients giving written informed consent will undergo a 1-week screening period to determine eliglibility for study entry at week 0, patients who meet the eligibility requirements will be randomized.
Study was conducted in two cohort Cohort 1. Patients with DMT2 and psoriasis, who are already on metformin therapy in the maximally tolerated dose and to whom semaglutide will be introduced into the therapy, in the maximum tolerated dose of semaglutide (0.25mg, 0.5mg per week or 1.0mg per week).
Cohort 2. Patients with DMT2 and psoriasis, who are already on metformin therapy in the maximally tolerated dose and other oral antidiabetics, except on therapy with GLP-1 RA and SGLT-2 inhibitors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| semaglutide | Experimental | The initial dose of the medicine is 0.25 mg once a week, for the duration of 4 weeks. Then the dose is increased to 0.5 mg per week, for the duration of 4 weeks. After at least 4 weeks, the dose can be increased from 0.5 mg to 1 mg per 4 week. Totally 12 weeks |
|
| controled group | No Intervention | Patients with DMT2 and psoriasis, who are already on metformin therapy in the maximally tolerated dose and other oral antidiabetics, except on therapy with GLP-1 RA and SGLT-2 inhibitors. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide | Drug | 0.25mg 4 weeks, 0.5mg per 4 weeks and 1.0mg per 4 weeks, totally 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| clinical characteristics of patients with psoriasis | clinical examination by a dermatovenerologist (PASI SCORE- Psoriasis Area and Severity Index). To assess disease activity, i.e. skin surface affected by changes (erythema, infiltration and extent of squamous matter), investigators used the PASI score. According to the European consensus, mild psoriasis is defined as PASI≤10 and DLQI≤10, while moderate psoriasis is defined as PASi>10 and DLQI>10. | up to 12 weeks |
| Determine BMI Body Mass Index | e.g., weight and height will be combined to report BMI in kg/m^2 | up to 12 weeks |
| Serum values of TNFa, IL-1b, IL-6, IL-17 and IL-23 | ELISA-Enyzme linked immunosorbent assay technique -Bio Legend ELISA MAX Deluxe Sets, Bio Legend, San Diego, CA. same units | up to12 weeks |
| Correlation between the course and prognosis of the disease after the treatment | the Wilcoxon Mann-Whitney test for two independent groups will be used. Spearman's correlation analysis will be used to determine the correlation between parameters, binary logistic regression | up to 12 weeks |
| Change in HgbA1C, | by enzymatic method with hexakinase glucose-6-phosphate dehydrogenase (Roche Diagnostic) will be expressed in % | up to 12 weeks |
| lipid status, change in Total cholesterol (TC), low-density lipoprotein(LDL), high-density lipoprotein (HDL) and triglicerides | Biochemical analyses Clinical colorimetric tests, and results will be expressed in same units |
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Inclusion Criteria:
Exclusion Criteria:
male and female
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| Name | Affiliation | Role |
|---|---|---|
| Jelena Petkovic-Dabic | Faculty of Medicine Banja Luka | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Banja Luka, Faculty of Medicine | Banja Luka | 78000 | Bosnia and Herzegovina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34463640 | Result | Costanzo G, Curatolo S, Busa B, Belfiore A, Gullo D. Two birds one stone: semaglutide is highly effective against severe psoriasis in a type 2 diabetic patient. Endocrinol Diabetes Metab Case Rep. 2021 Aug 1;2021:21-0007. doi: 10.1530/EDM-21-0007. Online ahead of print. | |
| 33068776 | Result | Nauck MA, Quast DR, Wefers J, Meier JJ. GLP-1 receptor agonists in the treatment of type 2 diabetes - state-of-the-art. Mol Metab. 2021 Apr;46:101102. doi: 10.1016/j.molmet.2020.101102. Epub 2020 Oct 14. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 8, 2023 | Jun 20, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 8, 2023 | Jun 20, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 8, 2023 | Jun 20, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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double (participant, investigator)
| up to 12 weeks |
| fasting insulin | Biochemical analyses | up to 12 weeks |
| Change in inflammation marker level: CRP, | Biochemical analyses-Turbid metric test | up to 12 weeks |
| fasting glycemia | by enzymatic method with hexakinase glucose-6-phosphate dehydrogenase (Roche Diagnostic) | up to 12 weeks |
| urate | Biochemical analyses | up to 12 weeks |
| D004700 | Endocrine System Diseases |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |