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Pre-diabetes Reversion Program in Beijing
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注册号:

Registration number:

ChiCTR-PRC-06000005 

最近更新日期:

Date of Last Refreshed on:

2015-04-19 

注册时间:

Date of Registration:

2006-05-18 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

北京糖尿病前期逆转研究 

Public title:

Pre-diabetes Reversion Program in Beijing 

注册题目简写:

BPRP 

English Acronym:

BPRP 

研究课题的正式科学名称:

北京糖尿病前期逆转研究 

Scientific title:

Beijing Pre-diabetes Reversion Program 

研究课题代号(代码):

Study subject ID:

D0905003040131 

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:

周翔海,罗樱樱 

研究负责人:

纪立农 

Applicant:

Xianghai Zhou, Yingying Luo 

Study leader:

Ji Linong 

申请注册联系人电话:

Applicant telephone:

+86 010 88324105 

研究负责人电话:

Study leader's telephone:

+86 010 88324108 

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:

yingyingluo@yahoo.com 

研究负责人电子邮件:

Study leader's E-mail:

jiln@bjmu.edu.cn 

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:

北京市西城区西直门南大街11号北京大学人民医院 

研究负责人通讯地址:

北京市西城区西直门南大街11号北京大学人民医院 

Applicant address:

No 11, Xizhimen South Street, Xicheng District, Beijing, China 

Study leader's address:

No 11, Xizhimen South Street, Xicheng District, Beijing, China 

申请注册联系人邮政编码:

Applicant postcode:

100044 

研究负责人邮政编码:

Study leader's postcode:

100044 

申请人所在单位:

北京大学人民医院 

Applicant's institution:

People's Hospital, Peking University 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

IRB00001052-06069 

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:

北京大学医学部伦理委员会 

Name of the ethic committee:

Ethic Committee of Peking University Health Science Center 

伦理委员会批准日期:

Date of approved by ethic committee:

2006-12-01 

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:

北京大学人民医院 

Primary sponsor:

People's Hospital, Peking University 

研究实施负责(组长)单位地址:

北京市西城区西直门南大街11号北京大学人民医院 

Primary sponsor's address:

No 11, Xizhimen South Street, Xicheng District, Beijing, 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):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京市科学技术委员会

具体地址:

北京

Institution
hospital:

Beijing Municipal Science & Technology Committee

Address:

Beijing, China

经费或物资来源:

北京市科学技术委员会 

Source(s) of funding:

Beijing Municipal Science & Technology Committee 

研究疾病:

糖尿病 

Target disease:

Diabetes 

研究疾病代码:

 

Target disease code:

 

研究类型:

预防性研究 

Study type:

Prevention 

研究所处阶段:

上市后药物 

Study phase:

研究目的:

在糖尿病前期的人群中验证采用强化生活方式干预措施和在强化生活方式干预基础上加用药物干预措施使糖尿病前期逆转为正常血糖并改善与之相关的心血管危险因子的有效性和安全性。 

Objectives of Study:

To evaluate the efficacy of intensive lifestyle intervention or pioglitazone 30mg QD as well as the combination of theses two strategies in conversion to normal glycemic status and improvement of cardiovaslucar risk factors in patients with pre-diabetes. 

药物成份或治疗方案详述:

吡格列酮 

Description for medicine or protocol of treatment in detail:

Pioglitazone 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

(一)自愿参加试验,并签署受试者知情同意书。 (二)糖尿病前期患者 糖尿病前期定义为: 1、空腹血糖受损(IFG):FPG≥6.1mmol/L(110mg/dl)且<7.0mmol/L(126mg/dl),同时75g葡萄糖负荷后2hPG<7.8mmol/L(140mg/dl) 2、糖耐量减低(IGT):FPG<7.0mmol/L(126mg/dl),同时75g葡萄糖负荷后2hPG≥7.8mmol/L(140mg/dl)且<11.1mmol/L(200mg/dl)。 3、按照世界卫生组织糖尿病分类标准,如果同时具有IGT和IFG,则诊断为IGT。 (三)男性和女性均可。 (四)民族不限。 (五)25岁≤年龄≤70岁。 (六)22kg/m2≤BMI<35 kg/m2 

Inclusion criteria

1. Voluntarily participate the trial and sign subject's informed consent form; 2. Clinical diagnosis of PrediabetesIFG: fasting plasma glucose 36.1mmol/L(100mg/dl) and <7.0mmol/L(126mg/dl) and/orIGT: 2h plasma glucose; 3. 7.8mmol/L(140mg/dl) and <11.1mmol/L(200mg/dl) after a 75g oral glucose loadTo meet the World Health Organization criteria of prediabetes, IGT subjects also include those who have both IGT and IFG; 4. Ethnicity: All ethnic groups; 5. Gender: Male and female; 6. Age: Individuals aged 25-70 years old; 7. Body mass index: 22kg/m2

排除标准:

(一)在基线时有以下任何情况可诊断的糖尿病: 1、空腹血浆葡萄糖≥7.0 mmol/L(126 mg/dL); 2、OGTT测定2小时血浆葡萄糖≥11.1 mmol/L(200 mg/dL); 3、医生诊断的糖尿病并且有其他临床数据证实(如空腹血浆葡萄糖≥7.0 mmol/L [126 mg/dL]或OGTT诊断的糖尿病)。病人报告既往被诊断糖尿病,但既没有应用降血糖药物也没有临床数据证实糖尿病的需要在临床中心进行OGTT判断; 4、既往应用降血糖药物(妊娠糖尿病除外)。 (二)过去6个月内新诊断的冠心病,过去6个月内新发的心肌梗死或不稳定性心绞痛,以及过去6个月内曾因心脏疾病或脑卒中住院治疗。 (三)纽约心脏病学会标准(NYHA)评价心功能≥2级或目前应用袢类利尿剂或洋地黄类药物治疗。 (四)左束支传导阻滞,Ⅲ度房室传导阻滞,或其他严重心律失常。 (五)未得到控制的高血压:治疗后任何一次血压测量收缩压>160 mmHg或舒张压>100 mmHg。轻度的高血压仍提倡接受初步的观察和治疗,不应该被排除。 (六)其他由临床医生判断的不适合参加本研究的严重心、脑血管疾病。 (七)严重的肺部疾病。 (八)近期曾行腹部手术,或既往有重大腹部手术史。 (九)胃肠道疾病(胰腺炎,炎症性肠病)。 (十)自述慢性肝炎或肝硬化,或者血清AST或ALT上升达下述标准:血清AST≥2.5倍正常值上限或血清ALT≥2.5倍正常值上限。 (十一)有以下任何泌尿系统疾病: 1、血清肌酐≥133 μmol/L (1.5 mg/dL); 2、没有泌尿系统感染或阴道分泌物污染的情况下尿蛋白定量测定阳性。 3、既往有膀胱癌病史。 4、肉眼血尿或镜下血尿(每高倍视野红细胞>3个) (十二)血常规中血红蛋白<110g/L。 (十三)现患Graves病或甲状腺功能减退症,无论甲状腺功能是否正常。 (十四)现患影响糖代谢的内分泌疾病(Cushing's 综合征,肢端肥大症,嗜铬细胞瘤,泌乳素瘤,低血糖症等)。 (十五)无论是否接受治疗,一次空腹血浆甘油三酯水平>6.77 mmol/L(600 mg/dL)。 (十六)癌症或目前接受抗肿瘤药物治疗者。 (十七)严重肢体功能性疾病,可能影响体力活动者。 (十八)活动性结核或目前正在接受抗结核药物治疗者。 (十九)具有以下任何情况者:严重的精神心理疾患、目前正在接受抗精神心理疾病药物治疗、酒精滥用或依赖、药物滥用或依赖。 (二十)目前接受以下任何药物治疗:噻嗪类利尿剂、β受体阻断剂治疗、烟酸类药物降脂治疗、全身应用糖皮质激素(但不包括局部、眼部和吸入应用)、减肥药物(包括近3个月内曾使用者)。 (二十一)对盐酸吡格列酮过敏或其中成分过敏者。 (二十二)正在怀孕或哺乳(不包括6周内将结束哺乳的妇女)以及研究期间有怀孕计划的妇女,和/或进入试验前和/或试验期间不能采用充分的避孕措施的妇女(充分的避孕措施包括绝育、使用宫内节育器、口服避孕药或使用避孕套)。 (二十三)除了临产后的体重减轻,在过去6个月内任何原因导致的体重减轻>10%。 (二十四)家庭中另外一个成员是本试验的工作人员或参加研究的受试者。 (二十五)目前或先前参加了另外的干预研究项目可能会影响干预效果。 (二十六)在今后3年内可能移居至其他城市。 (二十七)研究者认为受试者存在任何不适合进入本研究的其他情况。 

Exclusion criteria:

1. Diabetes at baseline: (1)Fasting plasma glucose>7.0 mmol/L(126 mg/dL); (2)2-h plasma glucose >11.1 mmol/L(200 mg/dL) after a 75g oral glucose load; (3)Diabetes diagnosed by physicians with other clinical evidence to support [such as FPG >7.0 mmol/L(126 mg/dL) or diabetes diagnosed by OGTT]; If the patients report diabetes history by themselves without any clinical evidence, and the patients have never used any antidiabetic drugs, then the clinical staff has to perform an OGTT at the site; (4)Receive antidiabetic treatment at any time before (except gestational diabetes); 2. Newly diagnosed coronary artery disease or myocardial infarction, unstable angina in the past 6 months. Hospitalization for the treatment of heart disease or stroke in the past 6 months; 3. New York Heart Association Functional Class >2 or currently treated with a loop diuretic or digitalis preparation; 4. Left bundle branch block on ECG, third degree atrioventricular block on ECG, or other severe arrhythmia; 5. Uncontrolled hypertension: SBP>160 mmHg or DBP>100 mmHg on treatment. Milder degrees of hypertension would prompt referral to primary care provider for treatment (with compatible agent of the trial) but would not exclude; 6. Other severe heart diseases or cerebral vascular diseases not specifically mentioned above may serve as criteria for exclusion at the discretion of the clinic site; 7. Severe pulmonary disease; 8. Recent or significant abdominal surgery; 9. Gastrointestinal disease (pancreatitis, inflammatory bowel disease); 10. Self-reported chronic hepatitis or cirrhosis, or serum AST or ALT elevated by the following criteria: Serum AST level is 2.5 fold elevated above the higher limit; Serum ALT level is 2.5 fold elevated above the higher limit. 11. Any renal disease mentioned as following: (1)Serum creatinine >133 umol/L (1.5 mg/dL); (2)Abnormal urine protein level based on a 24 hour urine collection on one occasion, in the absence of infection or vaginal contamination; (3)Bladder carcinoma history; (4)Gross hematuria or microscopic hematuria (red blood cell>3/hp). 12. Hb<110g/L in blood routine test; 13. Currently having graves disease or hypothyroidism, no matter the thyroid function is normal or abnormal; 14. Currently having disease associated with disordered glucose metabolism (Cushing's Syndrome, Acromegaly, Pheochromocytoma, prolactinoma, hypoglycemia, etc.); 15. Fasting plasma triglyceride level >600 mg/dL (6.77 mmol/L) on one occasion despite treatment 16. Cancer or being treated with antitumor drugs; 17. Severe extremity dysfunction, which may limit the life style intervention; 18. Active tuberculosis or receiving antituberculosis treatment currently; 19. Major psychiatric disorder or taking psychoactive agents currently. Excessive alcohol intake and/or drug abuse; 20. Taking thiazide diuretics or beta-blockers currently. Taking biacin as a lipid-lowering agents currently. Glucocorticoids other than topical, ophthalmic, and inhaled preparations. Taking weight reducing agent; 21. Allergic to pioglitazone or its component; 22. Currently pregnant or nursing (except for those who will complete nursing in 6 weeks), and pregnancy anticipated during study. Without enough contraceptive method (include sterilization, intrauterine contraceptive device, oral contraceptive agent or condom); 23. Weight loss of >10% in past 6 months for any reason except post-partum weight loss; 24. Another household member is a participant or staff member in the study; 25. Current or anticipated participation in another intervention research project that would interfere with any of the interventions offered in this trial; 26. Likely to move away from participating clinics in next 3 years; 27. Conditions not specifically mentioned above may serve as criteria for exclusion at the discretion of the clinic site. 

研究实施时间:

Study execute time:

From2007-01-01To 2013-02-28 

征募观察对象时间:

Recruiting time:

From2007-01-01To 2010-02-28 

干预措施:

Interventions:

组别:

试验1组

样本量:

500

Group:

Group 1

Sample size:

干预措施:

强化生活方式干预加安慰剂

干预措施代码:

Intervention:

Intensive lifestyle intervention plus placebo

Intervention code:

组别:

试验2组

样本量:

500

Group:

Group 2

Sample size:

干预措施:

标准生活方式干预加盐酸吡格列酮

干预措施代码:

Intervention:

Conventional lifestyle intervention plus pioglitazone

Intervention code:

组别:

试验3组

样本量:

500

Group:

Group 3

Sample size:

干预措施:

强化生活方式干预加盐酸吡格列酮

干预措施代码:

Intervention:

Intensive lifestyle intervention plus pioglitazone

Intervention code:

组别:

对照组

样本量:

500

Group:

control group

Sample size:

干预措施:

标准生活方式干预加安慰剂

干预措施代码:

Intervention:

Conventional lifestyle intervention plus placebo

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京大学人民医院 

单位级别:

三甲医院 

Institution
hospital:

Peking University People's Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京同仁医院 

单位级别:

三甲医院 

Institution
hospital:

Beijing Tongren Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京医院 

单位级别:

三甲医院 

Institution
hospital:

Beijing Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京军区总医院 

单位级别:

三甲医院 

Institution
hospital:

The Military General Hospital of Beijing PLA  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京协和医院 

单位级别:

三甲医院 

Institution
hospital:

Peking Union Medical Colledge Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

复兴医院 

单位级别:

三甲医院 

Institution
hospital:

Fuxing Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国人民解放军第二炮兵总医院 

单位级别:

三甲医院 

Institution
hospital:

The Second Artillery General Hospital of Chinese People's Liberation Army  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京市第六医院 

单位级别:

二级医院 

Institution
hospital:

Beijing No.6 Hospital  

Level of the institution:

Secondary hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

西城区展览路医院 

单位级别:

二级医院 

Institution
hospital:

Beijing Zhanlanlu Hospital  

Level of the institution:

Secondary hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京大学第三医院 

单位级别:

三甲医院 

Institution
hospital:

Peking University Third Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国人民解放军总医院第一附属(304)医院 

单位级别:

三甲医院 

Institution
hospital:

The 304th Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

解放军第309医院 

单位级别:

三甲医院 

Institution
hospital:

The 309th Hospital of Chinese People's Liberation Army  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

海军总医院 

单位级别:

三甲医院 

Institution
hospital:

Navy General Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

空军总医院 

单位级别:

三甲医院 

Institution
hospital:

Air Force General Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中日友好医院 

单位级别:

三甲医院 

Institution
hospital:

China-Japan Friendship Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京市海淀医院 

单位级别:

二级医院 

Institution
hospital:

Beijing Haidian Hospital  

Level of the institution:

Secondary hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国人民解放军第306医院 

单位级别:

三甲医院 

Institution
hospital:

The 306th Hospital of PLA  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京朝阳医院 

单位级别:

三甲医院 

Institution
hospital:

Beijing Chaoyang Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京市垂杨柳医 

单位级别:

二级医院 

Institution
hospital:

Beijing Chuiyangliu Hospital  

Level of the institution:

Secondary hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

煤炭总医院 

单位级别:

三甲医院 

Institution
hospital:

China Meitan General Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

民航总医院 

单位级别:

三甲医院 

Institution
hospital:

Civil Aviation General Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

宣武医院 

单位级别:

三甲医院 

Institution
hospital:

Xuanwu Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京天坛医院 

单位级别:

三甲医院 

Institution
hospital:

Beijing Tiantan Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京电力医院 

单位级别:

三甲医院 

Institution
hospital:

Beijing Electric Power Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

航天七三一医院 

单位级别:

二级医院 

Institution
hospital:

Aerospace 731 Hospital  

Level of the institution:

Secondary hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学潞河教学医院 

单位级别:

二级医院 

Institution
hospital:

The Luhe Teaching Hospital of the Capital Medical University  

Level of the institution:

Secondary hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京市大兴区人民医院 

单位级别:

二级医院 

Institution
hospital:

People's Hospital of Beijing Daxing District  

Level of the institution:

Secondary hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京市平谷区医院 

单位级别:

三级医院 

Institution
hospital:

Beijing Pinggu Hospital  

Level of the institution:

Tertiary hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

大兴中医院 

单位级别:

二级医院 

Institution
hospital:

Daxing Hospital of Tranditional Chinese Medicine  

Level of the institution:

Secondary hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京市和平里医院 

单位级别:

二级医院 

Institution
hospital:

Beijing Hepingli Hospital  

Level of the institution:

Secondary hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京大学首钢医院 

单位级别:

三级医院 

Institution
hospital:

Peking University Shougang Hospital  

Level of the institution:

Tertiary hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京市丰台区南苑医院 

单位级别:

二级医院 

Institution
hospital:

Nanyuan Hospital  

Level of the institution:

Secondary hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北郊医院 

单位级别:

二级医院 

Institution
hospital:

Beijiao Hospital  

Level of the institution:

Secondary hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

南法信医院 

单位级别:

一级 

Institution
hospital:

Nanfaxin Hospital  

Level of the institution:

Level one hospital 

测量指标:

Outcomes:

指标中文名:

糖尿病的发病率

指标类型:

主要指标 

Outcome:

Incidence rate of diabetes

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

指标类型:

主要指标 

Outcome:

The metabolism status of normalization of blood gl

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

6.心脑血管疾病

指标类型:

次要指标 

Outcome:

Incidence of heart diseases and cerebral vascular diseases

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

7.全因死亡

指标类型:

次要指标 

Outcome:

All cause mortality

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

3.高血压

指标类型:

次要指标 

Outcome:

Incidence of hypertension

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

5.血脂水平,空腹胰岛素水平, 炎症因子(hsCRP), 脂联素水平

指标类型:

次要指标 

Outcome:

Lipid profile, fasting insulin level, inflammatory factor (hsCRP), adiponectin

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

1.药物清洗期后血糖代谢状态

指标类型:

次要指标 

Outcome:

Glucose regulation evaluation after drug washout period

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

代谢综合征

指标类型:

次要指标 

Outcome:

Incidence of metabolic syndrome

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

4.体重,腰围

指标类型:

次要指标 

Outcome:

Body weight and waistline

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

药物安全性

指标类型:

副作用指标 

Outcome:

Safety Issue of Pioglitazone

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

正常血糖代谢状态

指标类型:

主要指标 

Outcome:

The metabolism status of normalization of blood glucose

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:

Sample Name:

Blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

尿液

组织:

Sample Name:

Urine

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 25 years
最大 Max age 72 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):

统计人员用SAS的PLAN过程进行分段随机化

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

Block randomization was performed by SAS Plan precedure by statisticians

盲法:

资料分析者 盲 结果测量者 盲 试验用药为随机双盲,生活方式干预不盲 受试者 盲 试验用药为随机双盲,生活方式干预不盲 研究申办方 盲 试验用药为随机双盲,生活方式干预不盲

Blinding:

Data analyse people: blinded Investigators: drug-blinded, lifestyle intervention-open label Paticipants: drug-blinded, lifestyle intervention-open label Applicants:drug-blinded, lifestyle intervention-open label

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

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):

北京大学医学部

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

Peking University Health Science Center

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:

北京大学医学部公共卫生学院

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

School of Public Health, Peking University

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2006-05-18
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