5-MTHF Supplementation for Treatment of Type 1 Diabetes Patients

NCT06930144 | Not Yet Recruiting

• 1 other identifier: CZYZ-5MTHF-2025-IIT
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Islet β cell function

  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.

  From enrollment to 24 weeks of treatment

Secondary Outcomes (6)

• HbA1c

  From enrollment to 24 weeks of treatment

• lymphocyte subsets

  From enrollment to 24 weeks of treatment

• islet autoantibodies

  From enrollment to 24 weeks of treatment

• insulin dosage

  24 weeks of treatment

• cytokines

  From enrollment to 24 weeks of treatment

Study Arms (2)

5-MTHF supplementation group

EXPERIMENTAL

basic diabetes treatment combined with 5-MTHF (5-Methyltetrahydrofolate)

Drug: active folate

placebo control group

PLACEBO COMPARATOR

basic diabetes treatment combined with placebo

Drug: Placebo

Interventions

active folate DRUG

Daily oral intake of active folate 800ug combined with basic diabetic treatment

Also known as: 5-Methyltetrahydrofolate

5-MTHF supplementation group

Placebo DRUG

take oral placebo daily combined with basic diabetic treatment

placebo control group

Eligibility Criteria

• Age: 13 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \) Signed informed consent form, with parental/guardian consent and signature required for pediatric/adolescent participants.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Changzheng Hospital: lead

Related Publications (3)

• Vukotic R, Di Donato R, Roncarati G, Simoni P, Renzulli M, Gitto S, Schepis F, Villa E, Berzigotti A, Bosch J, Andreone P. 5-MTHF enhances the portal pressure reduction achieved with propranolol in patients with cirrhosis: A randomized placebo-controlled trial. J Hepatol. 2023 Oct;79(4):977-988. doi: 10.1016/j.jhep.2023.06.017. Epub 2023 Jul 22.

  PMID: 37482222 RESULT

• Verhaar MC, Wever RM, Kastelein JJ, van Dam T, Koomans HA, Rabelink TJ. 5-methyltetrahydrofolate, the active form of folic acid, restores endothelial function in familial hypercholesterolemia. Circulation. 1998 Jan 27;97(3):237-41. doi: 10.1161/01.cir.97.3.237.

  PMID: 9462523 RESULT

• Giammarco S, Chiusolo P, Maggi R, Rossi M, Minnella G, Metafuni E, D'Alo F, Sica S. MTHFR polymorphisms and vitamin B12 deficiency: correlation between mthfr polymorphisms and clinical and laboratory findings. Ann Hematol. 2024 Oct;103(10):3973-3977. doi: 10.1007/s00277-024-05937-z. Epub 2024 Aug 28.

  PMID: 39196375 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

5-methyltetrahydrofolate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Qing Ling, doctor

CONTACT

86+19542790766; lynn_1018@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 16, 2025
• Study Start: April 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 16, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share