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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
34
Daily oral intake of active folate 800ug combined with basic diabetic treatment
take oral placebo daily combined with basic diabetic treatment
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.
Time frame: From enrollment to 24 weeks of treatment
HbA1c
glycated hemoglobin (HbA1c) \<7·0% or ≥ 1% reduction of HbA1c levels from baseline
Time frame: From enrollment to 24 weeks of treatment
lymphocyte subsets
change in lymphocytes subsets
Time frame: From enrollment to 24 weeks of treatment
islet autoantibodies
type and titer of islet autoantibodies
Time frame: From enrollment to 24 weeks of treatment
insulin dosage
change in insulin dosage at 24 weeks of treatment
Time frame: 24 weeks of treatment
cytokines
change in serum cytokines
Time frame: From enrollment to 24 weeks of treatment
CRP
change in C-reactive protein
Time frame: From enrollment to 24 weeks of treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.