Effect of Semaglutide on the Inflammatory Response and Clinical Course of Psoriatic Lesions in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- clinical characteristics of patients with psoriasis
研究概览
简要总结
The use of semaglutide in patients with DMT2 and psoriasis contributes to improving the clinical picture of psoriasis and reducing the inflammatory response
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
double (participant, investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who signed a personal consent to participate in the study,
- •Patients with a typical clinical picture of moderately-severe to severe plaque psoriasis (PASI SCORE ≥10) and
- •DMT2 diagnosed at least 6 months before inclusion in the study,
- •Patients who were not treated with immunosuppressive therapy.
排除标准
- •Other forms of psoriasis,
- •Other chronic, inflammatory diseases (data obtained by reviewing the medical history),
- •Drugs that can cause the appearance of psoriasis (lithium, systemic antimalarials, systemic corticosteroids) - for the past 3 months,
- •Systemic therapy of vulgaris psoriasis 3 months before inclusion in the study,
- •Patients on therapy with other GLP-1 RAs except semaglutide (liraglutide, dulaglutide, lixisenatide), SGLT-2 inhibitors (empagliflozin and dapagliflozin) and NSAIDs, photo UVB therapy,
- •Patients who did not personally sign consent to participate in the study.
研究组 & 干预措施
semaglutide
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
干预措施: Semaglutide (Drug)
结局指标
主要结局
clinical characteristics of patients with psoriasis
时间窗: up to 12 weeks
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.
fasting glycemia
时间窗: up to 12 weeks
by enzymatic method with hexakinase glucose-6-phosphate dehydrogenase (Roche Diagnostic)
urate
时间窗: up to 12 weeks
Biochemical analyses
Serum values of TNFa, IL-1b, IL-6, IL-17 and IL-23
时间窗: up to12 weeks
ELISA-Enyzme linked immunosorbent assay technique -Bio Legend ELISA MAX Deluxe Sets, Bio Legend, San Diego, CA. same units
Change in HgbA1C,
时间窗: up to 12 weeks
by enzymatic method with hexakinase glucose-6-phosphate dehydrogenase (Roche Diagnostic) will be expressed in %
Change in inflammation marker level: CRP,
时间窗: up to 12 weeks
Biochemical analyses-Turbid metric test
Determine BMI Body Mass Index
时间窗: up to 12 weeks
e.g., weight and height will be combined to report BMI in kg/m\^2
Correlation between the course and prognosis of the disease after the treatment
时间窗: up to 12 weeks
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
lipid status, change in Total cholesterol (TC), low-density lipoprotein(LDL), high-density lipoprotein (HDL) and triglicerides
时间窗: up to 12 weeks
Biochemical analyses Clinical colorimetric tests, and results will be expressed in same units
fasting insulin
时间窗: up to 12 weeks
Biochemical analyses
次要结局
未报告次要终点