Clinical trial NCT06402760: Comprehensive Intervention of Diabetes and Psoriasis Comorbidity Prevention and Control
Official title: A Cohort Study on Comprehensive Intervention of Diabetes and Psoriasis Comorbidity Prevention and Control Using Traditional Chinese Medicine of Blood-activating and Stasis-dissolving Method
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Psoriasis
Diabetes
Lead sponsor: Shanghai Yueyang Integrated Medicine Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Hongkou District Center for Disease Control And Prevention
First posted: 2024-05-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: We will recruit 300 patients with psoriasis from Yueyang Hospital of Integrative Medicine, Shanghai University of Traditional Chinese Medicine, who will not be currently diagnosed with diabetes but will have been identified as high-risk individuals based on the developed risk assessment model. Based on doctor's treatment opinions and patient preferences, participants will be divided into two groups in a 1:1 ratio: a Western medicine group and a TCM comprehensive treatment group.

Patients in the Western medicine group will receive treatment according to guidelines. Patients in the TCM comprehensive treatment group will be treated according to the guidelines and will additionally receive Taodan granules (to be taken daily during the treatment period after brewing the granules with lukewarm water in the morning and evening) and fish oil (1g, taken orally twice daily).

Patients in the TCM comprehensive treatment group will be required to complete at least 150 minutes of moderate-intensity aerobic exercise per week under the supervision of a physician. The patients will be treated for 16 weeks and followed up for 24 weeks to see if the treatment prevents the development of diabetes or insulin resistance.


Eligibility criteria: Inclusion Criteria:

1. Meet the Western medicine diagnostic criteria for vulgaris psoriasis and the Traditional Chinese Medicine diagnostic criteria for blood stasis syndrome in psoriasis.
2. Newly diagnosed or previously diagnosed with psoriasis; if previously diagnosed, prior treatment methods are not restricted.
3. Identified as high risk for comorbid diabetes based on a risk model calculation.
4. Age between 18 and 80 years old, any gender.
5. Willing to participate in this study and provide informed consent.

Exclusion Criteria:

1. Patients already diagnosed with diabetes.
2. Presence of other active skin diseases that may affect the assessment of the condition.
3. In severe, difficult-to-control acute or chronic infection locally or systemically.
4. Severe systemic diseases; or patients with clinical laboratory indicators falling into any of the following conditions:

   ① Hematology: Hemoglobin (HGB) \< 90g/L; Platelet count (PLT) \< 10010\^9/L; White blood cell count (WBC) \< 310\^9/L; Absolute neutrophil count (NEUT) \< 1.5\*10\^9/L;

   ② Liver function: Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) exceeding 3 times the upper limit of normal (ULN) or total bilirubin exceeding 1.5 times the upper limit of normal;

   ③ Renal function: Serum creatinine greater than 1.5 times the upper limit of normal;

   ④ Other abnormal laboratory test results judged by the investigator to potentially affect the patient's completion of the trial or interfere with the trial results.
5. History of malignant tumors and primary or secondary immunodeficiency or hypersensitivity.
6. Underwent major surgery within 8 weeks or will require such surgery during the study period.
7. Pregnant or lactating women.
8. History of alcoholism, drug abuse, or substance abuse.
9. History of severe mental illness or family history thereof.
10. Family history of tumors.
11. Other reasons deemed inappropriate for participation by the investigator.

Primary outcomes:
measure: The number of participants assessed for diabetes prevention efficacy based on Glycated Hemoglobin (HbA1c)
timeFrame: Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40)
measure: The number of participants assessed for diabetes prevention efficacy based on Fasting Plasma Glucose (FPG)
timeFrame: Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40)
measure: The number of participants assessed for diabetes prevention efficacy based on Postprandial 2-hour Plasma Glucose (PPG)
timeFrame: Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40)
measure: The number of participants assessed for diabetes prevention efficacy based on Fasting Insulin (FINS)
timeFrame: Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40)
measure: The number of participants assessed for diabetes prevention efficacy based on C-peptide
timeFrame: Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40)
measure: The number of participants assessed for psoriasis improvement efficacy due to clinical intervention based on Improvement of PASI (Psoriasis Area and Severity Index).
timeFrame: Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40)
Secondary outcomes:
measure: The number of participants assessed for improvement in metabolic indicators related to comorbid psoriasis and diabetes due to clinical intervention based on serum triglyceride (TG) evaluation.
timeFrame: Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).
measure: The number of participants assessed for improvement in metabolic indicators related to comorbid psoriasis and diabetes due to clinical intervention based on Serum Total Cholesterol (TC) evaluation.
timeFrame: Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).
measure: The number of participants assessed for improvement in metabolic indicators related to comorbid psoriasis and diabetes due to clinical intervention based on erum High-Density Lipoprotein Cholesterol (HDL) evaluation.
timeFrame: Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).
measure: The number of participants assessed for improvement in metabolic indicators related to comorbid psoriasis and diabetes due to clinical intervention based on Serum Low-Density Lipoprotein Cholesterol (LDL) evaluation.
timeFrame: Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).
measure: The number of participants assessed for improvement in metabolic indicators related to comorbid psoriasis and diabetes due to clinical intervention based on Serum Apolipoprotein AI (ApoAI) evaluation.
timeFrame: Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).
measure: The number of participants assessed for improvement in metabolic indicators related to comorbid psoriasis and diabetes due to clinical intervention based on Serum Apolipoprotein B (ApoB) evaluation.
timeFrame: Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).
measure: The number of participants assessed for improvement in metabolic indicators related to comorbid psoriasis and diabetes due to clinical intervention based on Serum Lipoprotein α evaluation.
timeFrame: Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).
measure: The number of participants assessed for improvement in metabolic indicators related to comorbid psoriasis and diabetes due to clinical intervention based on Serum small dense low-density lipoprotein (sdLDL) evaluation.
timeFrame: Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).
measure: Assessing the number of participants experiencing a decrease in levels of inflammatory biomarkers associated with the comorbidity of psoriasis and diabetes using HsCRP
timeFrame: Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).
measure: Assessing the number of participants experiencing a decrease in levels of inflammatory biomarkers associated with the comorbidity of psoriasis and diabetes using IL-1β
timeFrame: Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).
measure: Assessing the number of participants experiencing a decrease in levels of inflammatory biomarkers associated with the comorbidity of psoriasis and diabetes using IL-6
timeFrame: Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).
measure: Assessing the number of participants experiencing a decrease in levels of inflammatory biomarkers associated with the comorbidity of psoriasis and diabetes using TNFα
timeFrame: Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).
measure: Assessing the number of participants experiencing a decrease in levels of inflammatory biomarkers associated with the comorbidity of psoriasis and diabetes using IL-17A
timeFrame: Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).
measure: Assessing the number of participants experiencing a decrease in levels of inflammatory biomarkers associated with the comorbidity of psoriasis and diabetes using FGL1
timeFrame: Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).
measure: The number of participants assessed for psoriasis improvement efficacy due to clinical intervention based on Improvement of Body Surface Area (BSA).
timeFrame: Assessed at screening (Week 0), Week 4, Week 8, Week 12, Week 16 of treatment, and during follow-up (Week 20, Week 24, Week 28, Week 32, Week 36, Week 40).
measure: The number of participants assessed for psoriasis improvement efficacy due to clinical intervention based on Improvement of Physician's Global Assessment (PGA).
timeFrame: Assessed at screening (Week 0), Week 4, Week 8, Week 12, Week 16 of treatment, and during follow-up (Week 20, Week 24, Week 28, Week 32, Week 36, Week 40).
measure: The number of participants assessed for psoriasis improvement efficacy due to clinical intervention based on Improvement of Dermatology Life Quality Index (DLQI).
timeFrame: Assessed at screening (Week 0), Week 4, Week 8, Week 12, Week 16 of treatment, and during follow-up (Week 20, Week 24, Week 28, Week 32, Week 36, Week 40).
measure: The number of participants assessed for psoriasis improvement efficacy due to clinical intervention based on Improvement of Psoriasis-related Quality of Life (PRQoL).
timeFrame: Assessed at screening (Week 0), Week 4, Week 8, Week 12, Week 16 of treatment, and during follow-up (Week 20, Week 24, Week 28, Week 32, Week 36, Week 40).
measure: The number of participants assessed for psoriasis improvement efficacy due to clinical intervention based on Improvement of self-assessment of itching symptoms (VAS) score.
timeFrame: Assessed at screening (Week 0), Week 4, Week 8, Week 12, Week 16 of treatment, and during follow-up (Week 20, Week 24, Week 28, Week 32, Week 36, Week 40).
measure: The number of participants assessed for psoriasis improvement efficacy due to clinical intervention based on Improvement of Traditional Chinese Medicine symptom score.
timeFrame: Assessed at screening (Week 0), Week 4, Week 8, Week 12, Week 16 of treatment, and during follow-up (Week 20, Week 24, Week 28, Week 32, Week 36, Week 40).
Other outcomes:
Locations:
Study officials:
References: