碳水化合物摄入量变化对 1 型糖尿病患者血糖控制的影响
2026年9月7日 更新者：Yang Tao
碳水化合物摄入量变化对 1 型糖尿病患者血糖控制的影响。
T1DM患者血糖波动较大，尤其是在疾病中晚期，碳水化合物（CHO）是餐后血糖反应（PGR）的主要决定因素。
在前期了解营养习惯如何影响血糖控制的调查基础上，我们将对T1DM患者进行饮食干预研究，探讨饮食模式的调整是否有利于血糖控制，并通过检测相关指标进一步探讨相关机制。代谢指标。
研究概览
详细说明
1. 主要目的：评估碳水化合物摄入量变化对 1 型糖尿病患者血糖控制的影响。
- 主要终点：两组之间的射程时间差 (TIR)。
- 次要终点：
1)两组间变异系数(CV)、平均血糖波动幅度(MAGE)、血糖波动幅度(LAGE)的差异； 2）两组间HbA1c，GA，1,5-脱水葡萄糖醇（1,5-AG）较基线变化的差异； 3）两组间低血糖事件发生率变化（%）、严重低血糖和夜间低血糖事件发生率较基线的差异； 4) 两组之间胰岛素剂量（IU/kg/天）相对于基线的变化差异。
2.次要目标：探讨饮食干预改善1型糖尿病患者血糖控制的可能机制。
- 饮食干预对1型糖尿病患者肠道微环境和微生物群的影响
- 饮食干预对1型糖尿病患者免疫功能的影响
- 饮食干预对1型糖尿病患者代谢组学的影响。
研究类型
介入性
注册 (估计的)
80
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Tao Yang, MD/PhD
- 电话号码：6466 86-25-83718836
- 邮箱：yangt@njmu.edu.cn
学习地点
-
-
Jiangsu
-
Nanjing、Jiangsu、中国、210029
- 招聘中
- First Affiliated Hospital, Nanjing Medical University
-
接触：
- Tao Yang, PhD
- 电话号码：6466 86-25-83718836
- 邮箱：yangt@njmu.edu.cn
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
纳入标准：
- 同意参加研究并签署知情同意书者；
- 1型糖尿病的诊断（ADA2024）；
- 年龄18~65岁；
- 依赖外源性胰岛素治疗（CSII），2个月内治疗方案不变（不能改变胰岛素种类，可根据血糖调整剂量）；
- 体重指数（BMI）为18~24 kg/m2；
- 糖化血红蛋白≤9.5%；
- 随机C肽≥200pmol/L。
排除标准：
- 患有 1 型糖尿病的蜜月夫妇；
- 怀孕或计划怀孕的女性；
- 素食患者；
- 正在使用口服降糖药物（α-葡萄糖苷酶抑制剂、DPP-IV抑制剂等）的患者；
- 30天内使用过糖皮质激素的患者；
- 有严重食物过敏史；
- 患有DKA等急性并发症的患者；
- 患有胃轻瘫、炎症性肠病等并发症的患者；
- 大量蛋白尿和肾功能不全的患者；
- 未控制的甲状腺功能亢进症和甲状腺功能减退症患者；
- 有心脏病、冠心病及心律失常病史；
- 严重肝功能障碍（ALT或AST>正常上限的1.5倍）；
- 恶性肿瘤病史、未控制的其他免疫系统疾病、未控制的感染；
- 酗酒、精神障碍或有其他不适合担任药检观察员的情况；
- 患有任何可能干扰研究参与或评估的疾病的患者。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：diverse carbohydrate diet
Carbohydrate, protein, and fat provide 45-55%, 15-20%, and 25-35% of total dietary energy, respectively. Of the staple carbohydrate sources, 45-50% are derived from refined grains and 45-50% from whole grains and legumes. Total daily energy intake is divided among three meals, with breakfast providing 25-30% of total energy, lunch 30-40%, and dinner 30-35%. |
Carbohydrate, protein, and fat provide 45-55%, 15-20%, and 25-35% of total dietary energy, respectively.
Of the staple carbohydrate sources, 45-50% are derived from refined grains and 45-50% from whole grains and legumes.
Total daily energy intake is divided among three meals, with breakfast providing 25-30% of total energy, lunch 30-40%, and dinner 30-35%.
|
|
其他：moderate carbohydrate diet
Carbohydrate, protein, and fat provide 45-55%, 15-20%, and 25-35% of total dietary energy, respectively. Of the staple carbohydrate sources, 90-95% are derived from refined grains. Total daily energy intake is divided among three meals, with breakfast providing 25-30% of total energy, lunch 30-40%, and dinner 30-35%. |
Carbohydrate, protein, and fat provide 45-55%, 15-20%, and 25-35% of total dietary energy, respectively.
Of the staple carbohydrate sources, 90-95% are derived from refined grains.
Total daily energy intake is divided among three meals, with breakfast providing 25-30% of total energy, lunch 30-40%, and dinner 30-35%.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time in range (TIR)
大体时间：4 weeks (2 weeks after randomization)
|
TIR is defined as the percentage of time that glucose levels are between 3.9 and 10.0 mmol/L, as measured by continuous glucose monitoring (CGM).
TIR at the end of the 2-week dietary intervention will be compared between the two groups.
|
4 weeks (2 weeks after randomization)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time above range(TAR)
大体时间：4 weeks (2 weeks after randomization)
|
TAR is defined as the percentage of time that glucose levels are above 10.0 mmol/L, as measured using continuous glucose monitoring (CGM).
TAR at the end of the 2-week dietary intervention will be compared between the two groups.
|
4 weeks (2 weeks after randomization)
|
|
Time below range(TBR)
大体时间：4 weeks (2 weeks after randomization)
|
TBR is defined as the percentage of time that glucose levels are below 3.9 mmol/L, as measured using continuous glucose monitoring (CGM).
TBR at the end of the 2-week dietary intervention will be compared between the two groups.
|
4 weeks (2 weeks after randomization)
|
|
Mean glucose (MG)
大体时间：4 weeks (2 weeks after randomization)
|
Mean glucose is defined as the arithmetic mean of all valid glucose values recorded during the 2-week continuous glucose monitoring (CGM) period.
Mean glucose at the end of the 2-week dietary intervention will be compared between the two groups.
|
4 weeks (2 weeks after randomization)
|
|
Standard deviation of glucose (SD)
大体时间：4 weeks (2 weeks after randomization)
|
SD is a continuous glucose monitoring (CGM)-derived measure of glycemic variability.
SD at the end of the 2-week dietary intervention will be compared between the two groups.
|
4 weeks (2 weeks after randomization)
|
|
Glucose coefficient of variation (CV)
大体时间：4 weeks (2 weeks after randomization)
|
CV is a continuous glucose monitoring (CGM)-derived measure of glycemic variability.
CV at the end of the 2-week dietary intervention will be compared between the two groups.
|
4 weeks (2 weeks after randomization)
|
|
Mean amplitude of glycemic excursions (MAGE)
大体时间：4 weeks (2 weeks after randomization)
|
MAGE is a continuous glucose monitoring (CGM)-derived measure of glycemic variability.
MAGE at the end of the 2-week dietary intervention will be compared between the two groups.
|
4 weeks (2 weeks after randomization)
|
|
Largest amplitude of glycemic excursions (LAGE)
大体时间：4 weeks (2 weeks after randomization)
|
LAGE is a continuous glucose monitoring (CGM)-derived measure of glycemic variability.
LAGE at the end of the 2-week dietary intervention will be compared between the two groups.
|
4 weeks (2 weeks after randomization)
|
|
Glycated albumin (GA)
大体时间：4 weeks (2 weeks after randomization)
|
Glycated albumin will be measured at the end of the 2-week dietary intervention and compared between the two groups.
|
4 weeks (2 weeks after randomization)
|
|
Glycated hemoglobin A1c (HbA1c)
大体时间：16 weeks (14 weeks after randomization)
|
HbA1c will be measured at the end of the follow-up period and compared between the two groups.
|
16 weeks (14 weeks after randomization)
|
|
C-peptide area under the curve (AUC C-peptide)
大体时间：16 weeks (14 weeks after randomization)
|
C-peptide area under the curve will be assessed during a 3-hour mixed-meal tolerance test and calculated using the trapezoidal rule.
The assessment will be performed in participants with fasting C-peptide >80 pmol/L.
|
16 weeks (14 weeks after randomization)
|
|
Glucagon area under the curve (AUC glucagon)
大体时间：16 weeks (14 weeks after randomization)
|
Glucagon area under the curve will be assessed during a 3-hour mixed-meal tolerance test and calculated using the trapezoidal rule.
The assessment will be performed in participants with fasting C-peptide >80 pmol/L.
|
16 weeks (14 weeks after randomization)
|
|
Fasting blood glucose (FBG)
大体时间：4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
Fasting blood glucose will be measured at the end of the dietary intervention and at the end of the follow-up period and compared between the two groups.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
|
Total cholesterol (TC)
大体时间：4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
Total cholesterol will be measured at the end of the dietary intervention and at the end of the follow-up period and compared between the two groups.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
|
Triglycerides (TG)
大体时间：4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
Triglycerides will be measured at the end of the dietary intervention and at the end of the follow-up period and compared between the two groups.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
|
Low-density lipoprotein cholesterol (LDL-C)
大体时间：4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
LDL-C will be measured at the end of the dietary intervention and at the end of the follow-up period and compared between the two groups.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
|
High-density lipoprotein cholesterol (HDL-C)
大体时间：4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
HDL-C will be measured at the end of the dietary intervention and at the end of the follow-up period and compared between the two groups.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
|
1,5-Anhydroglucitol (1,5-AG)
大体时间：4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
1,5-AG will be measured at the end of the dietary intervention and at the end of the follow-up period and compared between the two groups.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
|
Total daily insulin dose
大体时间：4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
Total daily insulin dose, expressed as IU/kg/day, will be assessed at the end of the dietary intervention and at the end of the follow-up period.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
|
Basal insulin dose
大体时间：4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
Basal insulin dose, expressed as IU/kg/day, will be assessed at the end of the dietary intervention and at the end of the follow-up period.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
|
Prandial insulin dose
大体时间：4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
Prandial insulin dose, expressed as IU/kg/day, will be assessed at the end of the dietary intervention and at the end of the follow-up period.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
|
Body weight
大体时间：4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
Body weight will be measured at the end of the dietary intervention and at the end of the follow-up period.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
|
Waist circumference
大体时间：4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
Waist circumference will be measured at the end of the dietary intervention and at the end of the follow-up period.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
|
Hip circumference
大体时间：4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
Hip circumference will be measured at the end of the dietary intervention and at the end of the follow-up period.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
|
Waist-to-hip ratio (WHR)
大体时间：4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
Waist-to-hip ratio will be calculated from waist and hip circumference measurements at the end of the dietary intervention and at the end of the follow-up period.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
|
Body composition
大体时间：4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
Body composition will be assessed using a body composition analyzer at the end of the dietary intervention and at the end of the follow-up period.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
|
Hypoglycemic events
大体时间：From randomization to the end of follow-up at 16 weeks
|
Hypoglycemic events will be assessed by the number of events per participant, the proportion of participants experiencing at least one hypoglycemic event, and the incidence rate of hypoglycemic events.
|
From randomization to the end of follow-up at 16 weeks
|
|
Diabetic ketoacidosis (DKA)
大体时间：From randomization to the end of follow-up at 16 weeks
|
The number and proportion of participants experiencing diabetic ketoacidosis will be assessed and compared between the two groups.
|
From randomization to the end of follow-up at 16 weeks
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Gut microbiota profile
大体时间：4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
Gut microbiota profiles will be assessed from fecal samples at the end of the dietary intervention and at the end of the follow-up period to evaluate differences between the two groups.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
|
Metabolomic profile
大体时间：4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
Metabolomic profiles will be assessed at the end of the dietary intervention and at the end of the follow-up period to evaluate differences between the two groups.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
|
T-cell subset proportions
大体时间：4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
The proportions of T-cell subsets will be assessed by flow cytometry at the end of the dietary intervention and at the end of the follow-up period.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 首席研究员：Tao Yang, MD/PhD、First Affiliated Hospital, Nanjing Medical University, China
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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- Vetrani C, Calabrese I, Cavagnuolo L, Pacella D, Napolano E, Di Rienzo S, Riccardi G, Rivellese AA, Annuzzi G, Bozzetto L. Dietary determinants of postprandial blood glucose control in adults with type 1 diabetes on a hybrid closed-loop system. Diabetologia. 2022 Jan;65(1):79-87. doi: 10.1007/s00125-021-05587-0. Epub 2021 Oct 23.
- Kanikarla-Marie P, Jain SK. Hyperketonemia and ketosis increase the risk of complications in type 1 diabetes. Free Radic Biol Med. 2016 Jun;95:268-77. doi: 10.1016/j.freeradbiomed.2016.03.020. Epub 2016 Mar 29.
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2024年8月1日
初级完成 (估计的)
2027年12月31日
研究完成 (估计的)
2027年12月31日
研究注册日期
首次提交
2023年2月23日
首先提交符合 QC 标准的
2024年2月16日
首次发布 (实际的)
2024年2月22日
研究记录更新
最后更新发布 (实际的)
2026年9月10日
上次提交的符合 QC 标准的更新
2026年9月7日
最后验证
2026年9月1日
更多信息
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