Type 1 diabetes
Conditions
Interventions
Treatment group:Selenium yeast tablets + diabetes basic treatment program
Control Group:Placebo + basic diabetes treatment
Sponsors
Sir Run Run Hospital, Nanjing Medical University
Eligibility
Sex/Gender
All
Age
13 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. According to the World Health Organization (WHO) disease diagnostic criteria classification T1D; 2. Age =13 years old, gender unlimited; 3. Course of T1D disease =5 years; 4. Retain certain islet function, defined as fasting C-peptide >100 pmol/L[0.30 ng/mL] or random C-peptide >200 pmol/L[0.60 ng/mL]); 5. Able and willing to perform the following procedures as determined by the investigator: self-glucose monitoring (SMBG); Fill in the patient log as required; Diabetes education is available; Compliance with protocol requirements for investigational treatment and investigational visits. 6. Sign informed consent. Children/adolescent subjects must obtain the informed consent of their legal guardians and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Blood trace element selenium level exceeded the upper limit of normal reference value; 2. Currently in acute metabolic disorders, such as diabetic ketoacidosis, hypertonic hyperglycemia, etc.; 3. Women who are breastfeeding, pregnant or who ask to become pregnant during the trial; 4. Received immunosuppressive or regulatory drug therapy within 1 year; 5. Associated with other autoimmune diseases, such as systemic lupus erythematosus; 6. Severe diseases of liver, kidney, gastrointestinal tract, blood system, brain and circulatory system; 7. The woman is pregnant, breastfeeding or plans to become pregnant within 6 months; 8. Mental and nervous system diseases, failure to cooperate or take medication on time, abuse drugs or other substances, etc.; Malignant tumor; 9. 10. Known hypersensitivity or allergic reaction to selenium yeast or its excipients; 11. Surgery or stress; 12. The investigator judges that there is clear evidence of severe, active, uncontrolled endocrine or autoimmune abnormalities in the patient; 13. Is participating in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum C-peptide;HbA1C; | — |
Secondary
| Measure | Time frame |
|---|---|
| The dosage of basic diabetes drug;Self-glucose monitoring;Serum glucose;Serum insulin;Islet autoantibodies;Lymphocyte subsets in peripheral blood;Cytokines level;C-reactive protein; | — |
Countries
China
Contacts
Public ContactYu Liu
Sir Run Run Hospital, Nanjing Medical University
Outcome results
None listed