Comprehensive Intervention of Diabetes and Psoriasis Comorbidity Prevention and Control

NCT06402760 | Not Yet Recruiting Early Phase 1

• 1 other identifier: GWVI-11.1-24
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Psoriasis; Diabetes

Outcome Measures

Primary Outcomes (6)

• The number of participants assessed for diabetes prevention efficacy based on Glycated Hemoglobin (HbA1c)

  The members of the two groups will measure glycosylated hemoglobin (HbA1c) in Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine at the 16th week of treatment and the follow-up period (40th week) to judge whether diabetes or insulin resistance occurs.

  Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40)

• The number of participants assessed for diabetes prevention efficacy based on Fasting Plasma Glucose (FPG)

  The members of the two groups will measure Fasting Plasma Glucose (FPG) in Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine at the 16th week of treatment and the follow-up period (40th week) to judge whether diabetes or insulin resistance occurs.

  Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40)

• The number of participants assessed for diabetes prevention efficacy based on Postprandial 2-hour Plasma Glucose (PPG)

  The members of the two groups will measure Plasma Glucose (PPG) in Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine at the 16th week of treatment and the follow-up period (40th week) to judge whether diabetes or insulin resistance occurs.

  Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40)

• The number of participants assessed for diabetes prevention efficacy based on Fasting Insulin (FINS)

  The members of the two groups will measure Fasting Insulin (FINS) in Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine at the 16th week of treatment and the follow-up period (40th week) to judge whether diabetes or insulin resistance occurs.

  Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40)

• The number of participants assessed for diabetes prevention efficacy based on C-peptide

  The members of the two groups will measure C-peptide in Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine at the 16th week of treatment and the follow-up period (40th week) to judge whether diabetes or insulin resistance occurs.

  Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40)

• The number of participants assessed for psoriasis improvement efficacy due to clinical intervention based on Improvement of PASI (Psoriasis Area and Severity Index).

  Improvement of PASI= PASI at week 0 - PASI at week 16 and week 40.

  Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40)

Secondary Outcomes (20)

• 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.

  Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).

• 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.

  Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).

• 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.

  Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).

• 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.

  Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).

• 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.

  Assessed at screening (Week 0), Week 16 of treatment, and during follow-up (Week 40).

Study Arms (2)

Western medicine group

ACTIVE COMPARATOR

Treatment will be stratified according to the severity of psoriasis in patients, with therapeutic methods limited to the traditional treatment approaches outlined in the Chinese Guidelines for the Diagnosis and Treatment of Psoriasis (2023 Simplified Version). The treatment duration will be 16 weeks, followed by a 24-week follow-up period during which patients will not be restricted in their treatment modalities.

Drug: Western medicine

TCM comprehensive treatment group

EXPERIMENTAL

In addition to the Western medicine treatment prescribed in the guidelines, patients are required to take fish oil orally and Taodan Granules, and engage in moderate to high-intensity aerobic exercise weekly.

Other: TCM comprehensive treatment

Interventions

TCM comprehensive treatment OTHER

1. Taodan Granules (TCM formulation for promoting blood circulation and removing blood stasis): The granules consist of the following herbal components: milkvetch, licorice, angelica, rhizoma chuanxiong, peach seed, Salvia miltiorrhiza, Curcuma zedoaria, Achyranthes bidentata, and sarsaparilla. Patients will take it orally in two divided doses after breakfast and dinner. 2. Fish Oil: Patients will take 1g of fish oil orally twice daily. Patients will be instructed to purchase fish oil under the guidance of the researchers. 3. Exercise Plan: Researchers will design an exercise plan for patients, who will be required to engage in at least 150 minutes of moderate-intensity aerobic exercise per week. Patients will undergo a 16-week treatment period followed by a 24-week follow-up period. During the follow-up, patients will continue taking fish oil and adhering to the exercise regimen, while other treatment modalities will be unrestricted.

TCM comprehensive treatment group

Western medicine DRUG

The treatment methods prescribed in the guidelines.

Western medicine group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients already diagnosed with diabetes.
• Presence of other active skin diseases that may affect the assessment of the condition.
• In severe, difficult-to-control acute or chronic infection locally or systemically.
• 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.
• History of malignant tumors and primary or secondary immunodeficiency or hypersensitivity.
• Underwent major surgery within 8 weeks or will require such surgery during the study period.
• Pregnant or lactating women.
• History of alcoholism, drug abuse, or substance abuse.
• History of severe mental illness or family history thereof.
• Family history of tumors.
• Other reasons deemed inappropriate for participation by the investigator.

Sponsors & Collaborators

• Shanghai Yueyang Integrated Medicine Hospital: lead
• Shanghai Hongkou District Center for Disease Control And Prevention: collaborator

MeSH Terms

Conditions

Psoriasis; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Xin Li

CONTACT

13661956326; 13661956326@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: May 7, 2024
• Study Start: July 1, 2024
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share