Psoriasis combined with type 2 diabetes
Conditions
Interventions
intervention group:Secuchiumab 300mg, QW, subcutaneous injection, changed to every 4 weeks after 5 weeks
Sponsors
Chu Hsien-I Memorial Hospital of Tianjin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75, male or female; 2. Subjects voluntarily agree to participate and sign informed consent; 3. Diagnosed with type 2 diabetes mellitus (WHO1999 standards); 4. Within three months, HbA1c <7%, the hypoglycemic regimen was stable; 5.HOMA-IR is greater than or equal to 3.4 6.The diagnosis is consistent with moderate to severe plaque psoriasis (2023 Chinese Psoriasis Guidelines)
Exclusion criteria
Exclusion criteria: 1. Blood transfusion or severe blood loss or known hemoglobiosis, hemolytic anaemia or sickle cell anaemia or any other condition that could interfere with the measurement of A1C in the 3 months prior to the first visit; 2. Have been diagnosed with or have had acute complications of diabetes (such as diabetic ketoacidosis, hyperglycemia hyperosmolar state, etc., within the past 6 months); 3. Major cardiovascular history within 3 months prior to screening, defined as myocardial infarction, coronary angioplasty or bypass grafting, valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accident; 4. Any other conditions that may prevent the patient from following and completing the trial protocol (such as known drug, alcohol, mental illness, etc.); 5. Pregnant or lactating women; 6. Patients with a history of chronic or recurrent infection, tuberculosis, Crohn's disease, etc.; 7. Other types of psoriasis, except plaque psoriasis; 8. Liver and kidney function is impaired or the treating physician considers that biological agents cannot be used; 9. Participation in another intervention study is currently under way. 10. Used biological agents in the past one year, and received abitrin A, cyclosporine a, methotrexate, tripterygium vine, and traditional Chinese medicine system treatment in the past one month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HOMAR-IR changes from baseline to week 52; | — |
Secondary
| Measure | Time frame |
|---|---|
| HOMAR-IR changes from baseline to week 24;HOMA2-IR, QUICKI, IAI, Gutt index (adjustable body weight), OGTT derived index Matsuda index, Stumvoll index, triglyceride glycemic index and Adipo-IRi were compared from baseline at week 24 and 52;Changes in waist-hip circumference, body weight, and BMI from baseline at weeks 16, 24, and 52;Changes in inflammatory cytokines from baseline at weeks 16, 24, and 52;Body composition changed from baseline at week 24 and 52;Changes in cognitive function, hypoglycemia and blood glucose fluctuations (CGMS), and large microvascular complications from baseline at week 52;Compared with baseline values, PASI 75/90/100 and PASI <3 ratio at 16, 24 and 52 weeks were measured on the Skin Life Scale DLQI; | — |
Countries
China
Contacts
Public ContactSong Zhen Qiang
Chu Hsien-I Memorial Hospital of Tianjin Medical University
Outcome results
None listed