Type 1 Diabetes MellitusNCT06930144
5-MTHF Supplementation for Treatment of Type 1 Diabetes Patients
A study testing active folate in people with Type 1 Diabetes Mellitus, run by Shanghai Changzheng Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 65 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- active folate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Apr 2025to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Immunomodulatory and Therapeutic Efficacy of 5-methyltetrahydrofolate Supplementation on Autoimmune Status in Type 1 Diabetes Mellitus
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
- Being tested
- active folate, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active folateDrug
Also called 5-Methyltetrahydrofolate
Daily oral intake of active folate 800ug combined with basic diabetic treatment
PlaceboDrug
take oral placebo daily combined with basic diabetic treatment
| Study group | Role | What they receive |
|---|---|---|
| 5-MTHF supplementation group | Experimental | basic diabetes treatment combined with 5-MTHF (5-Methyltetrahydrofolate) Receives: Drug: active folate |
| placebo control group | Placebo comparator | basic diabetes treatment combined with placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to 24 weeks of treatment
Secondary outcomes (6)
HbA1c
glycated hemoglobin (HbA1c) <7·0% or ≥ 1% reduction of HbA1c levels from baseline
Measured: From enrollment to 24 weeks of treatment
lymphocyte subsets
change in lymphocytes subsets
Measured: From enrollment to 24 weeks of treatment
islet autoantibodies
type and titer of islet autoantibodies
Measured: From enrollment to 24 weeks of treatment
insulin dosage
change in insulin dosage at 24 weeks of treatment
Measured: 24 weeks of treatment
cytokines
change in serum cytokines
Measured: From enrollment to 24 weeks of treatment
CRP
change in C-reactive protein
Measured: From enrollment to 24 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study startApr 2025 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Shanghai Changzheng HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06930144
- Sponsor's protocol ID
- CZYZ-5MTHF-2025-IIT
- Status last verified
- Mar 2025
- First submitted
- 8 Apr 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37482222Verhaar 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.
PubMed 9462523Giammarco 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.
PubMed 39196375
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunomodulatory and Therapeutic Efficacy of 5-methyltetrahydrofolate Supplementation on Autoimmune Status in Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06930144
- Acronym / sponsor ID
- CZYZ-5MTHF-2025-IIT
- Conditions
- Type 1 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 16 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5-MTHF supplementation group | Experimental | Drug: active folatebasic diabetes treatment combined with 5-MTHF (5-Methyltetrahydrofolate) |
| placebo control group | Placebo comparator | Drug: Placebobasic diabetes treatment combined with placebo |
Who may qualify
- Ages
- 13 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active folateAlso: 5-MethyltetrahydrofolateDaily oral intake of active folate 800ug combined with basic diabetic treatment | Drug | 5-MTHF supplementation group |
| Placebotake oral placebo daily combined with basic diabetic treatment | Drug | placebo control group |
Primary outcome
Islet β cell function
Time frame: 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.
6 secondary outcomes
HbA1c
Time frame: From enrollment to 24 weeks of treatment
lymphocyte subsets
Time frame: From enrollment to 24 weeks of treatment
islet autoantibodies
Time frame: From enrollment to 24 weeks of treatment
insulin dosage
Time frame: 24 weeks of treatment
cytokines
Time frame: From enrollment to 24 weeks of treatment
CRP
Time frame: From enrollment to 24 weeks of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Results publication: PubMed 37482222Vukotic 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.
- Results publication: PubMed 9462523Verhaar 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.
- Results publication: PubMed 39196375Giammarco 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.
- Individual participant dataSharing planned: No
Related trials for Type 1 Diabetes Mellitus
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing active folate in people with Type 1 Diabetes Mellitus, run by Shanghai Changzheng Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qing Ling, doctor (86+19542790766, lynn_1018@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Islet β cell function (time frame: From enrollment to 24 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06930144, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.