NCT06930144尚未招募不适用
Immunomodulatory and Therapeutic Efficacy of 5-methyltetrahydrofolate Supplementation on Autoimmune Status in Type 1 Diabetes Mellitus
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 34
- 主要终点
- Islet β cell function
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 13 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
5-MTHF supplementation group
Experimental
basic diabetes treatment combined with 5-MTHF (5-Methyltetrahydrofolate)
干预措施: active folate (Drug)
placebo control group
Placebo Comparator
basic diabetes treatment combined with placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Islet β cell function
时间窗: 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.
次要结局
- lymphocyte subsets(From enrollment to 24 weeks of treatment)
- HbA1c(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)
- CRP(From enrollment to 24 weeks of treatment)
研究者
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