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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5-MTHF supplementation group | Experimental | basic diabetes treatment combined with 5-MTHF (5-Methyltetrahydrofolate) |
|
| placebo control group | Placebo Comparator | basic diabetes treatment combined with placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active folate | Drug | Daily oral intake of active folate 800ug combined with basic diabetic treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | glycated hemoglobin (HbA1c) <7·0% or ≥ 1% reduction of HbA1c levels from baseline | From enrollment to 24 weeks of treatment |
| lymphocyte subsets | change in lymphocytes subsets |
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Inclusion Criteria:
6) Signed informed consent form, with parental/guardian consent and signature required for pediatric/adolescent participants.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qing Ling, doctor | Contact | 86+19542790766 | lynn_1018@126.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37482222 | Result | 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. | |
| 9462523 |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C005984 | 5-methyltetrahydrofolate |
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| Placebo | Drug | take oral placebo daily combined with basic diabetic treatment |
|
| From enrollment to 24 weeks of treatment |
| islet autoantibodies | type and titer of islet autoantibodies | From enrollment to 24 weeks of treatment |
| insulin dosage | change in insulin dosage at 24 weeks of treatment | 24 weeks of treatment |
| cytokines | change in serum cytokines | From enrollment to 24 weeks of treatment |
| CRP | change in C-reactive protein | From enrollment to 24 weeks of treatment |
| 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. |
| 39196375 | 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. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |