Status:
NOT_YET_RECRUITING
5-MTHF Supplementation for Treatment of Type 1 Diabetes Patients
Lead Sponsor:
Shanghai Changzheng Hospital
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
13-65 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- Diagnosed with T1D based on the World Health Organization (WHO) classification criteria for disease diagnosis.
- Aged 13-65 years, regardless of gender.
- Duration of T1D ≤ 5 years.
- 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 \[0.60 ng/mL\].
- 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
- Serum 5-methyltetrahydrofolate or folate levels exceeding the upper limit of the normal reference range.
- Currently experiencing acute metabolic disorders, such as diabetic ketoacidosis or hyperosmolar hyperglycemic state.
- Women who are breastfeeding, pregnant, or planning to become pregnant during the trial.
- Received immunosuppressive or immunomodulatory therapy within the past year.
- Comorbid with other autoimmune diseases, such as systemic lupus erythematosus.
- Severe liver, kidney, gastrointestinal, hematologic, cerebral, or circulatory system diseases.
- Psychiatric or neurological disorders leading to non-cooperation, non-adherence to medication, substance abuse, or other related issues.
- Malignancy.
- Recent surgery or significant stress.
- Known hypersensitivity or allergic reaction to 5-methyltetrahydrofolate or its excipients.
- Investigator's judgment of significant evidence of severe, active, or uncontrolled endocrine or autoimmune abnormalities.
- Currently participating in another clinical trial.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT06930144
Start Date
April 1 2025
End Date
April 1 2027
Last Update
April 16 2025
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