5-MTHF Supplementation for Treatment of Type 1 Diabetes Patients

Launched by SHANGHAI CHANGZHENG HOSPITAL · Apr 8, 2025

Keywords

ClinConnect Summary

This clinical trial is looking into the effects of a supplement called 5-Methyltetrahydrofolate (5-MTHF) on patients with Type 1 Diabetes (T1D). The goal is to see if this supplement can improve the autoimmune status of T1D patients and to explore how safe and effective this treatment is. By researching this, the study hopes to find new ways to help manage T1D and improve the overall quality of life for those living with the condition.

To participate in this trial, individuals need to be between 13 and 65 years old, have been diagnosed with T1D for five years or less, and still have some remaining ability for their body to produce insulin. Participants will need to monitor their blood sugar levels, keep track of their health in logs, and attend regular visits as outlined in the study. However, certain criteria may exclude individuals, such as having other serious health conditions or currently taking certain medications. If you or a loved one is interested, it’s important to discuss eligibility and any questions with a healthcare provider.

Gender

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Eligibility criteria

• 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.