Type 1 Diabetes Mellitus
Conditions
Brief summary
This study aims to evaluate the improvement of autoimmune status in patients with Type 1 Diabetes (T1D) through supplementation with 5-Methyltetrahydrofolate, and to explore the safety and efficacy of this treatment. The research seeks to provide new methods for the treatment of T1D and offer innovative ideas for enhancing the quality of life of T1D patients.
Interventions
DRUGactive folate
Daily oral intake of active folate 800ug combined with basic diabetic treatment
DRUGPlacebo
take oral placebo daily combined with basic diabetic treatment
Sponsors
Shanghai Changzheng Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
13 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosed with T1D based on the World Health Organization (WHO) classification criteria for disease diagnosis. 2. Aged 13-65 years, regardless of gender. 3. Duration of T1D ≤ 5 years. 4. Retained residual islet function, defined as fasting C-peptide \> 0.1 nmol/L \[0.30 ng/mL\] or postprandial 2-hour C-peptide \> 0.2 nmol/L \[0.60 ng/mL\]. 5. Determined by the investigator to be capable and willing to: perform self-monitoring of blood glucose (SMBG); complete patient logs as required; receive diabetes education; and comply with the study treatment and visit schedule as per the protocol. 6\) Signed informed consent form, with parental/guardian consent and signature required for pediatric/adolescent participants.
Exclusion criteria
1. Serum 5-methyltetrahydrofolate or folate levels exceeding the upper limit of the normal reference range. 2. Currently experiencing acute metabolic disorders, such as diabetic ketoacidosis or hyperosmolar hyperglycemic state. 3. Women who are breastfeeding, pregnant, or planning to become pregnant during the trial. 4. Received immunosuppressive or immunomodulatory therapy within the past year. 5. Comorbid with other autoimmune diseases, such as systemic lupus erythematosus. 6. Severe liver, kidney, gastrointestinal, hematologic, cerebral, or circulatory system diseases. 7. Psychiatric or neurological disorders leading to non-cooperation, non-adherence to medication, substance abuse, or other related issues. 8. Malignancy. 9. Recent surgery or significant stress. 10. Known hypersensitivity or allergic reaction to 5-methyltetrahydrofolate or its excipients. 11. Investigator's judgment of significant evidence of severe, active, or uncontrolled endocrine or autoimmune abnormalities. 12. Currently participating in another clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Islet β cell function | From enrollment to 24 weeks of treatment | Change in the area under curve (0-180min) of the serum C-peptide during the MMTT (Mixed Meal Tolerance Test) at 24 weeks of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| lymphocyte subsets | From enrollment to 24 weeks of treatment | change in lymphocytes subsets |
| islet autoantibodies | From enrollment to 24 weeks of treatment | type and titer of islet autoantibodies |
| HbA1c | From enrollment to 24 weeks of treatment | glycated hemoglobin (HbA1c) \<7·0% or ≥ 1% reduction of HbA1c levels from baseline |
| cytokines | From enrollment to 24 weeks of treatment | change in serum cytokines |
| CRP | From enrollment to 24 weeks of treatment | change in C-reactive protein |
| insulin dosage | 24 weeks of treatment | change in insulin dosage at 24 weeks of treatment |
Contacts
Primary ContactQing Ling, doctor
Outcome results
None listed