NCT06930144Not yet recruiting
5-MTHF Supplementation for Treatment of Type 1 Diabetes Patients
Immunomodulatory and Therapeutic Efficacy of 5-methyltetrahydrofolate Supplementation on Autoimmune Status in Type 1 Diabetes Mellitus
Source: ClinicalTrials.gov · Last updated 16 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 34 (estimated)
- First submitted
- 8 Apr 2025
- Start date
- Apr 2025
- Primary completion date
- Apr 2026
- Lead sponsor
- Shanghai Changzheng Hospital
- Diseases
- Type 1 diabetes
- NCT number
- NCT06930144
What you commit to
- Study type: Interventional
- Planned participants: 34
- From Apr 2025 to the primary completion date, Apr 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received immunosuppressive or immunomodulatory therapy within the past year.
- Recent surgery or significant stress.
Other illness
- Currently experiencing acute metabolic disorders, such as diabetic ketoacidosis or hyperosmolar hyperglycemic state.
- 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.
- 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.
Lab values
- Serum 5-methyltetrahydrofolate or folate levels exceeding the upper limit of the normal reference range.
Other
- Women who are breastfeeding, pregnant, or planning to become pregnant during the trial.
- Currently participating in another clinical trial.
Who the study is looking for
- 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.
Age in the registry: 13 years to 65 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.