5-MTHF Supplementation for Treatment of Type 1 Diabetes Patients

Not Applicable

Not yet recruiting

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Drug: active folate; Drug: Placebo

• Registration Number: NCT06930144
• Lead Sponsor: Shanghai Changzheng Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-04
• Study First Submitted: 2025-04-08
• Study First Submitted QC: 2025-04-08
• Last Update Submitted: 2025-04-08
• Study First Posted: 2025-04-16
• Last Update Posted: 2025-04-16
• Primary Completion: 2026-04
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5-MTHF supplementation group	active folate	basic diabetes treatment combined with 5-MTHF (5-Methyltetrahydrofolate)
placebo control group	Placebo	basic diabetes treatment combined with placebo

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
HbA1c	From enrollment to 24 weeks of treatment	glycated hemoglobin (HbA1c) \<7·0% or ≥ 1% reduction of HbA1c levels from baseline
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
insulin dosage	24 weeks of treatment	change in insulin dosage at 24 weeks of treatment
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