研究疾病:
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糖尿病
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研究疾病代码:
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Target disease:
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diabetes
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Target disease code:
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研究类型:
Study type:
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观察性研究
Observational study
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研究设计:
Study design:
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析因分组(即根据危险因素或暴露因素分组)
Factorial
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研究所处阶段:
Study phase:
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探索性研究/预试验
Pilot clinical trial
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研究目的:
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本研究拟采用多组学协同的系统生物学技术,基于临床横断面研究及病证结合动物模型从基因转录-蛋白表达-代谢特征-微生态结构等多层面构建T2DM病证时空演变的动态靶标网络,揭示中医证候生物学基础,并通过有效复方对动物模型的干预进一步验证靶标网络的准确性;同时应用网络药理学及生物信息技术全面解析中医药干预的复杂机制,并选取核心组分进行细胞验证,结合动物模型的机制探讨以揭示多种药效成分的协同作用模式,最终从整体上阐明中医治疗T2DM的“调态”、“打靶”作用内涵。
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Objectives of Study:
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This study intends to use multi-omics collaborative systems biology technology, based on clinical cross-sectional studies and disease-symptom combination animal models to construct dynamic targets for the temporal and spatial evolution of T2DM disease and syndrome from multiple aspects such as gene transcription, protein expression, metabolic characteristics, and microecological structure. Network, revealing the biological basis of TCM syndromes, and further verifying the accuracy of the target network through the intervention of effective compound prescriptions on animal models; at the same time, using network pharmacology and bioinformatics technology to comprehensively analyze the complex mechanism of TCM intervention, and select the core components Cell verification was carried out, combined with the mechanism study of animal models to reveal the synergistic mode of multiple medicinal components, and finally to clarify the connotation of "regulating state" and "targeting" of T2DM in the treatment of T2DM as a whole.
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药物成份或治疗方案详述:
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本研究采用流行病学横断面研究方法,根据诊断标准、纳入标准、排除标准选取符合糖尿病前期(郁阶段)、早期(热阶段)患者各60例,以及健康人群30例,系统性收集患者一般临床资料及临床化验指标数据、采集受试者血液、尿液、粪便样品,进行代谢组学、蛋白质组学、转录组学、元基因组学等检测,初步分析2型糖尿病郁热阶段人群表型组学的分布特征。
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Description for medicine or protocol of treatment in detail:
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In this study, an epidemiological cross-sectional study method was adopted. According to the diagnostic criteria, inclusion criteria and exclusion criteria, 60 patients with prediabetes (stagnation stage), 60 patients with early stage (fever stage), and 30 healthy people were selected systematically. Clinical data and clinical laboratory index data, collect blood, urine, and stool samples from subjects, perform metabolomics, proteomics, transcriptomics, metagenomics and other tests, and preliminarily analyze the phenotype group of the type 2 diabetes stagnant fever stage population distributional characteristics.
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纳入标准:
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入选标准-郁阶段
1) 符合2014年《中国成人2型糖尿病预防的专家共识》中糖尿病前期的诊断标准者;
2) 符合肝郁气滞证诊断;
3) 年龄18-70岁;
4) 既往未使用过糖尿病相关治疗药物者;
5) 签署知情同意书者。
入选标准-热阶段
1) 根据1999年WHO标准,符合早中期2型糖尿病诊断标准的初发或初治患者,经过筛选期(饮食控制+运动疗法4周)后空腹血糖≥7.0mmol/L,但空腹血糖<13.9mmol/L,或餐后2h血糖≥11.1mmol/L;且糖化血红蛋白≥7.0%;
2) 符合肠道湿热证诊断;
3) 年龄18-70岁;
4) 签署知情同意书者。
入选标准-健康人
1) 符合健康人的诊断标准,中医体质判定为平和质;
2) 年龄:18-70 岁;
3) 血糖正常范围内;
4) 签署知情同意书者。
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Inclusion criteria
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Inclusion Criteria - Depression Stage
1) Those who meet the diagnostic criteria for prediabetes in the "Expert Consensus on Prevention of Type 2 Diabetes in Chinese Adults" in 2014;
2) Conform to the diagnosis of liver qi stagnation syndrome;
3) Age 18-70 years old;
4) Those who have never used diabetes-related drugs before;
5) Those who signed the informed consent form.
Inclusion Criteria - Hot Stage
1) According to the 1999 WHO criteria, the newly diagnosed or newly treated patients who meet the diagnostic criteria of early and mid-stage type 2 diabetes, after the screening period (diet control + exercise therapy for 4 weeks), fasting blood glucose ≥ 7.0mmol/L, but fasting blood glucose <13.9 mmol/L, or 2h postprandial blood glucose ≥11.1mmol/L; and glycosylated hemoglobin ≥7.0%;
2) In line with the diagnosis of intestinal damp-heat syndrome;
3) Age 18-70 years old;
4) Those who signed the informed consent.
Inclusion Criteria - Healthy People
1) Meet the diagnostic criteria of healthy people, and the TCM constitution is judged to be peaceful;
2) Age: 18-70 years old;
3) The blood sugar is within the normal range;
4) Those who signed the informed consent.
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排除标准:
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排除标准-郁阶段
1) 不符合诊断及纳入标准者;
2) 应激状态血糖升高者或继发性血糖升高者;
3) 精神疾病患者;
4) 同时服用其他降糖药物者;
5) 增殖期视网膜病变需要激光治疗者;
6) 伴有严重的心、脑、肝及肾脏疾患或其它系统严重疾病的患者;
7) 6个月内有急性心脑血管事件或心肌梗死者;
8) 由于各种原因不能配合试验进行者;
9) 妊娠、准备妊娠或哺乳期妇女。
排除标准-热阶段
1) 以糖尿病并发症为主症者,及有严重的心、肺、肝、肾、脑等并发症或合并其他严重原发性疾病者;
2) 血压未经控制或经控制后,收缩压≥160mmHg或(和)舒张压≥100mmHg 者,所服用降压药物剂量及种类不能保持稳定;
3) 近1个月内有糖尿病酮症、酮症酸中毒以及严重感染者;
4) 精神病患者;
5) 妊娠、准备妊娠或哺乳期妇女;
6) 在过去5年内酗酒和/或精神活性物质,药物滥用者和依赖者;
7) 根据研究者的判断,具有降低入组可能性或使入组复杂化的其他病变或情况,如工作环境经常变动、生活环境不稳定等易造成失访的情况;
8) 肝、肾功能受损者(ALT、AST大于正常值上限2倍,血清肌酐大于正常值上限);
9) 已知对低血糖无症状者。
排除标准-健康人
1)诊断中患有呼吸系统、消化系统、内分泌系统、心血管系统等疾病者;
2)精神病患者;
3)妊娠、准备妊娠或哺乳期妇女。
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Exclusion criteria:
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Exclusion criteria - depression stage
1) Those who do not meet the diagnostic and inclusion criteria;
2) Those with elevated blood sugar in stress state or with secondary elevated blood sugar;
3) Patients with mental illness;
4) Those taking other hypoglycemic drugs at the same time;
5) Proliferative retinopathy requiring laser treatment;
6) Patients with severe heart, brain, liver and kidney diseases or other serious diseases of the system;
7) Patients with acute cardiovascular and cerebrovascular events or myocardial infarction within 6 months;
8) Those who cannot cooperate with the test due to various reasons;
9) Women who are pregnant, planning to become pregnant or breastfeeding.
Exclusion Criteria - Hot Phase
1) Those with diabetes complications as the main symptom, and those with severe heart, lung, liver, kidney, brain and other complications or combined with other serious primary diseases;
2) If the blood pressure is uncontrolled or controlled, the systolic blood pressure is ≥160mmHg or (and) the diastolic blood pressure is ≥100mmHg, and the dosage and type of antihypertensive drugs taken cannot be kept stable;
3) Patients with diabetic ketosis, ketoacidosis and severe infection within the past 1 month;
4) mentally ill patients;
5) Women who are pregnant, planning to become pregnant or breastfeeding;
6) Alcohol and/or psychoactive substances, drug abusers and dependents within the past 5 years;
7) According to the judgment of the researcher, there are other diseases or conditions that reduce the possibility of enrollment or complicate enrollment, such as frequent changes in the working environment and unstable living environment, which are likely to cause loss to follow-up;
8) Patients with impaired liver and kidney function (ALT and AST are greater than 2 times the upper limit of normal, and serum creatinine is greater than the upper limit of normal);
9) Known asymptomatic to hypoglycemia.
Exclusion Criteria - Healthy People
1) Those who suffer from diseases of the respiratory system, digestive system, endocrine system, cardiovascular system and other diseases during the diagnosis;
2) mentally ill patients;
3) Women who are pregnant, planning to become pregnant or breastfeeding.
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研究实施时间:
Study execute time:
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从From
2022-09-15
至To
2024-10-31
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征募观察对象时间:
Recruiting time:
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从From
2022-09-15
至To
2023-10-31
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