中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR1800014962
最近更新日期： Date of Last Refreshed on：	2018-02-25 11:51:34
注册时间： Date of Registration：	2018-02-25 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	间歇性断食对代谢性疾病的疗效和安全性
Public title：	The effect and safety of intermittent diet for metabolic diseases
注册题目简写：
English Acronym：
研究课题的正式科学名称：	间歇性断食对代谢性疾病的疗效和安全性
Scientific title：	The effect and safety of intermittent diet for metabolic diseases
研究课题代号(代码)： Study subject ID：
在二级注册机构或其它机构的注册号： The registration number of the Partner Registry or other register：

申请注册联系人：	问苏荣	研究负责人：	俞伟男
Applicant：	Wen Surong	Study leader：	Yu Weinan
申请注册联系人电话： Applicant telephone：	+86 15952152582	研究负责人电话： Study leader's telephone：	+86 13952195638
申请注册联系人传真： Applicant Fax：		研究负责人传真： Study leader's fax：
申请注册联系人电子邮件： Applicant E-mail：	1025420208@qq.com	研究负责人电子邮件： Study leader's E-mail：	452300365@qq.com
申请单位网址(自愿提供)： Applicant website(voluntary supply)：		研究负责人网址(自愿提供)： Study leader's website(voluntary supply)：
申请注册联系人通讯地址：	江苏省淮安市清江浦区淮海南路62号	研究负责人通讯地址：	江苏省淮安市清江浦区淮海南路62号
Applicant address：	62 Huaihai Road South, Qinjiangpu District, Huai'an, Jiangsu, China	Study leader's address：	62 Huaihai Road South, Qinjiangpu District, Huai'an, Jiangsu, China
申请注册联系人邮政编码： Applicant postcode：	223200	研究负责人邮政编码： Study leader's postcode：
申请人所在单位：	江苏省淮安市第二人民医院
Applicant's institution：	Endocrinology Department of The Second People's Hospital of Huai'an City, Jiangsu Province.
研究负责人所在单位：	江苏省淮安市第二人民医院
Affiliation of the Leader：	Endocrinology Department of The Second People's Hospital of Huai'an City, Jiangsu Province.

是否获伦理委员会批准：	否
Approved by ethic committee：	No
伦理委员会批件文号： Approved No. of ethic committee：		伦理委员会批件附件： Approved file of Ethical Committee：
批准本研究的伦理委员会名称：
Name of the ethic committee：
伦理委员会批准日期： Date of approved by ethic committee：	2013-08-26 00:00:00
伦理委员会联系人：
Contact Name of the ethic committee：
伦理委员会联系地址：
Contact Address of the ethic committee：
伦理委员会联系人电话： Contact phone of the ethic committee：		伦理委员会联系人邮箱： Contact email of the ethic committee：

研究实施负责（组长）单位：

江苏省淮安市第二人民医院内分泌科

Primary sponsor：

Endocrinology Department of The Second People's Hospital of Huai'an City, Jiangsu Province.

研究实施负责（组长）单位地址：

江苏省淮安市清江浦区淮海南路62号

Primary sponsor's address：

62 Huaihai Road South, Qinjiangpu District, Huai'an, Jiangsu, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	江苏省	市(区县)：	淮安市
Country：	China	Province：	Jiangsu	City：	Huai'an
单位(医院)：	江苏省淮安市第二人民医院	具体地址：	江苏省淮安市清江浦区淮海南路62号
Institution hospital：	Endocrinology Department of The Second People's Hospital of Huai'an City, Jiangsu Province	Address：	62 Huaihai Road South, Qinjiangpu District, Huai'an, Jiangsu, China

经费或物资来源：

包括其他部门的拨款、贷款、自筹及已取得的资助

Source(s) of funding：

Including funding from other departments, loans, self-financing and funding.

研究疾病：

代谢性疾病

Target disease：

metabolic diseases

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

其它

Study phase：

N/A

研究设计：

随机平行对照

Study design：

Parallel

研究目的：

通过调整饮食来提高细胞自噬，从而达到预防慢性病

Objectives of Study：

By adjusting the diet to improve autophagy, it can prevent chronic diseases.

药物成份或治疗方案详述：

A 断食指导：患者自愿、心情良好的接受断食。 1.心理状况不仅影响身体健康，而且影响断食期间的生理功能，例如蛋白质和脂肪代谢。在自愿良好执行断食期间，神经递质5-羟色胺，脑源性神经营养因子（BDNF）和内源性阿片样物质的增加也可产生情绪增强和欣快状态。 2.做好断食前准备：使用清肠酵素清洗胃肠道，可以在断食时减少肠蠕动，消除消化道中连续的基础分泌。予以适当有氧运动，注意休息及放松心情。 3.在7天的断食期间试验者不允许进食任何食物或具有能量的饮品，只可以饮用优质的山泉水。 4.复食。从第八天开始给受试者逐渐恢复饮食，复食必须循序渐进，逐渐增加，从流质到半流质，再到正常食物，从少量碳水化合物到蛋白质，再到脂肪等全营养素，复食时间共七天。第八天开始科恢复正常饮食。复食过程中，所有进食的是生态环保食物，确保不含农药、化肥等有毒有害物质。 B 其他饮食指导对于2型糖尿病、肥胖、高血压等代谢性疾病，国内外诸多的研究均已证实限制摄入量有一定的疗效。一般建议遵循健康平衡的膳食原则，包括增加高纤维低升糖指数的碳水化合物和鱼类、控制单糖和饱和反式脂肪酸的摄入。针对常见不良饮食行为，如非分食制的传统就餐方式、社交频繁、家庭成员的作用等，医护人员利用一切时机宣传科学饮食重要性，提倡个性化饮食，外出进餐应有节制，养成良好的饮食习惯，如低糖、低盐、低脂饮食，多食蔬菜，适量进食水果，限量饮酒等，通过宣传教育尽可能取得家庭成员的理解和支持，共同参与进一步提高饮食控制的执行能力。向患有代谢性疾病的患者提供依据每个患者实际情况专门制定的精准的多维实用饮食结构。 C运动指导: 合理正确的运动疗法，已逐步被人们所接受。有规律的运动可以改善机体的各种生理代谢指标，如血糖、血脂、体重、血压等；可使胰岛素敏感性增加、肝葡萄糖合成减少、增加肌肉组织对葡萄糖的吸收和利用、调节脂代谢、提高免疫力、改善心肺及神经内分泌功能等。可对代谢性疾病起到辅助治疗作用。运动前准备：运动前必须告知运动疗法的适应证和禁忌证。运动适宜任何人，但糖尿病伴酮症酸中毒、急性感染及活动性肺结核、缺血性心脏病者（尤其是不典型或无痛性心绞痛），糖尿病肥胖伴心、肝、肺、肾等严重脏器病变及严重的1型糖尿病除外。靶心率=170-年龄/分，一定要告知每天逐渐增加运动量，1周后达到靶心率，心功能评估欠佳者更如此。①运动形式：选择简单、方便，且以有氧运动为主。鼓励在有氧运动中适当加入肌肉力量训练，举重可增加肌肉重量，减少体脂量，调节脂代谢、改善胰岛素的敏感性。建议有氧耐力运动如步行、走跑交替、骑自行车、游泳、体操、太极拳等，高血压、肥胖型糖尿病患者采用较低强度运动，推荐世卫组织建议步行最好。②运动频率：每周4～5次，1周1次运动效果不好，且易产生肌肉酸痛和疲劳感，隔日运动效果好也不产生疲劳感。终止运动锻炼三天，已获得改善的胰岛素敏感性会随之消失。 D 心理指导: 代谢性疾病患者在发病过程可产生恐惧、内疚、焦虑、悲观、失望、忧郁、自弃、失落感等，糖尿病患者主要表现是抑郁和焦虑。抑郁和焦虑等心理障碍影响下丘脑释放某些神经递质，通过下丘脑、垂体、靶腺轴使胰岛细胞分泌胰岛素减少，升糖激素分泌增加，使神经内分泌免疫调节系统发生变化，导致血糖水平升高促发糖尿病。人处于焦虑状态时，血胰岛素含量减少，在感到孤独、绝望或抑郁时，胰岛素的需要量增加。糖尿病心理指导是药物治疗糖尿病成败的关键，糖尿病要实施个体化心理指导。同理，其他代谢性疾病亦需如此。宣教中应注意力求不用医学术语、讲解要有目的性和条理性。方法要灵活，还要注意动员家庭、单位以及社会的关注和配合，其中家庭成员最能掌握患者心境根源，他们参与可起到事半功倍的效果。 E降糖、降压治疗指导: 自我管理指导，让患者正确掌握电子血糖测量仪、血压仪等的使用，按时检测血糖、血压并即时记录。还要注意节假日、生病、应激等特殊时期的血糖、血压监测和药物调节，使患者看到自己控制血糖、血压下降的成功体验而获得自信，以期提高管理水平。

Description for medicine or protocol of treatment in detail：

A break food instruction: Patients are voluntarily and in a good mood. 1. Psychological condition affects not only physical health, but also physiological functions during the period of eating, such as protein and fat metabolism; The increase in neurotransmitter serotonin, brain-derived neurotrophic factor (BDNF), and endogenous opioid substances can also produce mood enhancement and euphoria during the voluntary and good exercise; 2. Prepare before breaking food: clean the gastrointestinal tract with clear intestinal enzyme, reduce intestinal peristalsis and eliminate the continuous base secretion in the digestive tract. Give proper cardio, rest and relax; 3. During the seven-day break, participants are not allowed to eat any food or drink with energy, and only drink high-quality spring water; 4. After eating: (1) From the eighth day start to participants gradually restore diet, food must be step by step, gradually increase, from the liquid to the, to the normal food, from a small amount of carbohydrates to proteins, and fats all nutrients, such as compound feed time seven days. On the eighth day, the family resumed normal diet. In the process of reeating, all the food is ecological and environmental protection food, so as to ensure free of pesticides, fertilizers and other poisonous and harmful substances. (2) other dietary guidelines. For metabolic diseases such as type 2 diabetes, obesity, hypertension and other metabolic diseases, many studies at home and abroad have confirmed that limited intake has certain curative effect. The general recommendation is to follow a healthy and balanced diet, including increasing the intake of carbohydrates and fish in high-fiber, low-glycemic index, and control of monosaccharide and saturated trans fats. For common poor eating behaviors, such as cockiness feed system of traditional dining way, social activity, the role of family members, such as medical staff use every opportunity promote scientific diet importance, advocate personalized diet, dine out should moderate, develop good eating habits, such as low sugar, low salt, low fat diet, eat more vegetables, right amount to eat fruit, limit alcohol, etc., through publicity and education on the understanding and support family members as soon as possible, to participate further improve the execution ability of diet control. Patients with metabolic diseases are provided with a precise multidimensional functional diet based on the actual conditions of each patient. (3) exercise guidance: Reasonable and correct exercise therapy has gradually been accepted by people. Regular exercise can improve the body's various physiological metabolic indicators, such as blood glucose, lipid, weight, blood pressure, etc. Can increase insulin sensitivity, hepatic glucose synthesis to reduce the absorption and utilization, increase muscle for glucose, regulate lipid metabolism, enhance immunity, improve heart and neuroendocrine function, etc. Metabolic diseases can play an auxiliary therapeutic role. Preparation before exercise: must be informed of the indications and contraindications of exercise therapy before exercise. Sport is suitable for anyone, but with diabetic ketoacidosis and active tuberculosis, acute infection, ischemic heart disease (especially atypical or painless angina pectoris), diabetes, obesity with serious organs such as heart, liver, lung, and kidney lesions and severe type 1 diabetes. The target rate =170- age/min. Be sure to increase the amount of physical activity gradually each day, and reach the target rate after 1 week. The form of movement: simple, convenient, and mainly aerobic. It is encouraged to add muscle strength training in aerobic exercise. Weight lifting can increase muscle weight, reduce body fat volume, regulate lipid metabolism and improve insulin sensitivity. Suggested aerobic endurance sports such as walking, go running, biking, swimming, gymnastics, alternately taijiquan, such as high blood pressure, fueling diabetes were treated by low intensity exercise, recommend who recommends on foot is best. Exercise frequency: 4 ~ 5 times a week, 1 week 1 time of exercise is not good, and easy to produce muscle pain and fatigue, the next day movement effect good also does not produce fatigue feeling. After three days of exercise, the improved insulin sensitivity will disappear. D psychological guidance: Patients with metabolic diseases can produce fear, guilt, anxiety, pessimism, disappointment, depression, self-abandonment, loss of feeling, etc., and the main symptoms of diabetic patients are depression and anxiety. Depression and anxiety and other psychological disorders affect the release of certain neurotransmitters, from the hypothalamus through the hypothalamus, pituitary, reduce islet cells secrete insulin target gland axis, rose sugar hormone secretion to increase, make the neuroendocrine immune regulation system change, lead to elevated blood sugar levels contribute to diabetes. When people are in a state of anxiety, their blood insulin levels decrease, and insulin needs increase when they feel lonely, desperate or depressed. The psychological guidance of diabetes is the key to the success of diabetes mellitus. The same is true for other metabolic diseases. In missionary education, we should be careful not to use medical terms and explanations to be purposeful and rational. The method should be flexible, and also pay attention to mobilize the attention and cooperation of the family, the unit and the society. Among them, the family members are the most able to master the mental root of the patients, and their participation can have the effect of half the effort. E. Treatment instruction for hypoglycemic and hypotensive therapy: Self-management guidance, let patients correctly grasp the use of electronic blood glucose meters, blood pressure meters and so on, timely detection of blood glucose, blood pressure and real-time records. Note also holidays, illness, stress and other special period of blood glucose, blood pressure monitoring and drug regulation, make the patients see their control of blood glucose, blood pressure decline success experience and gain confidence, in order to improve the level of management.

纳入标准：

Inclusion criteria

1. metabolic syndrome: the IDF global consensus, metabolic syndrome diagnosis of metabolic syndrome must meet the following conditions:
(1) the central obesity (Chinese male waist 90 cm or more, the female waist 80 cm or more, waist different RACES have their own reference);
(2) the merging two paragraphs in the following four indicators:
The level of triglyceride (TG) increased: > 150mg/dl (1.7mmol/l), or received corresponding treatment;
The level of high-density lipoprotein - cholesterol (hdl-c) decreased: men < 40mg/dl (0.9mmol/l), women < 50mg/dl (1.1mmol/l), or received corresponding treatment;
Elevated blood pressure: systolic blood pressure is greater than 130 or more than 85mm Hg, or has been treated or has been diagnosed with hypertension;
Fasting plasma glucose (FPG) increased: FPG was greater than 100mg/dl (5.6mmol/l), or had previously been diagnosed with type 2 diabetes or had been treated accordingly;
Oral glucose tolerance test (OGTT) is strongly recommended if the FPG is more than 100mg/dl (5.6mmol/l), but OGTT is not necessary to diagnose metabolic syndrome;
2. type 2 diabetes: according to the diagnostic criteria of who-1999 diabetes: fasting blood glucose is greater than 7.0mmol/L and (or) 2 hours greater than 11.1mmol/L, mild to moderate;
Body fat, BMI (weight kg/ height m2) is greater than 27;
The duration of the disease was not more than 5 years, and there was no obvious chronic complication of diabetes and no routine use of insulin therapy;
3. primary hypertension: according to the WHO and China's 1999 diagnostic criteria of hypertension, namely under the condition of not take antihypertensive medicine, not on the same day three measuring blood pressure, systolic blood pressure (pressure) or 140 MMHG and/or diastolic blood pressure (press) 90 MMHG or higher;
The patient has a history of hypertension and is currently using antihypertensive drugs, although the blood pressure is lower than 140/90mmhg and is also diagnosed as hypertension;
4. simple obesity: BMI BBB 0 30, excluding other organic diseases.

排除标准：

排除标准：（1）肾功能异常，血肌酐清除率小于60ml/min；（2）慢性心功能不全，心功能分级III级和以上；（3）严重的全身疾病患者。如肿瘤、血液系统疾病；（4）有低血糖病史患者；（5）妊娠、哺乳、不愿在研究期间避孕的育龄妇女；（6）有严重心、脑血管疾病者，或装有支架的患者；（7）血压持续高于180/110mmHg；（8）有严重胃肠道疾病者，如消化性溃疡、慢性腹泻等；（9）严重肺结核病人以及有传染病者；（10）精神病者或有精神病史者；（11）身体特别虚弱，生活不能自理者；（12）先天严重不足者(包括完全失去劳动力、听力、视力者、痴呆者)；（13）三个月内曾参加其它临床研究的患者。

Exclusion criteria：

(1) abnormal renal function, blood creatinine clearance rate less than 60ml/min;
(2) chronic cardiac dysfunction, level III and above of cardiac function;
(3) severe systemic disease;
Such as tumor, blood system disease;
(4) patients with a history of hypoglycemia;
(5) women of child-bearing age who are pregnant, breast-feeding and are not willing to use contraception during the study period;
(6) patients with severe heart, cerebrovascular disease, or patients with stents;
(7) blood pressure continued to be higher than 180/110mmhg;
(8) patients with severe gastrointestinal diseases, such as peptic ulcer and chronic diarrhea;
(9) patients with serious tuberculosis and infectious diseases;
(10) a person with mental illness or a history of mental illness;
(11) the body is particularly weak, and life cannot be self-reliant;
(12) congenital severe underachievers (including total loss of labor, hearing, vision, and dementia);
(13) patients who had participated in other clinical studies within three months.

研究实施时间：

Study execute time：

从 From 2018-03-01 00:00:00至 To 2020-03-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2018-03-01 00:00:00 至 To 2020-03-01 00:00:00

干预措施：

Interventions：

组别：	研究组	样本量：	80
Group：	Experimental group	Sample size：	80
干预措施：	饮食控制	干预措施代码：
Intervention：	alimentary control	Intervention code：

组别：	对照组	样本量：	80
Group：	control group	Sample size：	80
干预措施：	生活指导	干预措施代码：
Intervention：	living guidance	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	江苏省	市(区县)：	淮安市
Country：	China	Province：	Jiangsu	City：	Huai'an City
单位(医院)：	江苏省淮安市第二人民医院	单位级别：	三甲医院
Institution hospital：	Endocrinology Department o 's Hospital of Huai'an City, Jiangsu Province.	Level of the institution：	Tertiary A Hospital

测量指标：

Outcomes：

指标中文名：	血糖	指标类型：	主要指标
Outcome：	blood suger	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	血液	组织：	静脉
Sample Name：	blood	Tissue：	wein
人体标本去向	使用后销毁	说明	保存一年
Fate of sample：	Destruction after use	Note：	save a year

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：

最小 Min age	18	岁 years
最大 Max age	65	岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

专业检测人员，双盲

Randomization Procedure (please state who generates the random number sequence and by what method)：

Professional tester, double blind

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：
Blinding：
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

是否共享原始数据： IPD sharing	否No
共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：	2020-09-01，万方数据库
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	2020-09-01, wanfang database
数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：	电子采集和管理系统
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Electronic Data Capture
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2018-02-25 11:51:34