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Clinical Trial Details

Trial ID: L3210
Source ID: NCT06475586
Associated Drug: Semaglutide
Title: Effect of Semaglutide on the Psoriatic Lesions in Patients With Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Psoriasis Vulgaris|Diabetes Type 2
Interventions: DRUG: Semaglutide
Outcome Measures: Primary: 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, 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 |
Sponsor/Collaborators: Sponsor: University of Banja Luka
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 30
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-05-03
Completion Date: 2024-06-10
Results First Posted:
Last Update Posted: 2024-07-01
Locations: University of Banja Luka, Faculty of Medicine, Banja Luka, 78000, Bosnia and Herzegovina
URL: https://clinicaltrials.gov/show/NCT06475586