To Improve the Ability of Early Screening and Diagnosis in Patients With Diabetic Nephropathy
2022年5月23日 更新者：Yiming Mu
Healthy China - The Improvement Projects for the Screening Ability of Diabetes and Its Complications And for the Standardized Ability of Diagnosis and Treatment for Patients With Early Diabetic Nephropathy
This is a large-scale, multi-center, observational study.
It is planned to establish a large database of 10,000 patients with type 2 diabetes mellitus to investigate the prevalence, awareness and screening rates of diabetes kidney disease (DKD), and provide real-world data on the efficacy and safety of sodium glucose cotransporter 2 inhibitors (SGLT2i) in patients with type 2 diabetes mellitus (T2DM).
調査の概要
状態
招待による登録
条件
詳細な説明
Among the various complications of diabetes mellitus, DKD is considered as a major threat and is one of the manifestations of diabetic microangiopathy. it is one of the main causes of death for patients with T2DM.
Albuminuria is the earliest manifestation of DKD, which is mostly asymptomatic at the early stage, if the albuminuria is poorly controlled, it may develop into clinical DKD. Therefore, it is very important to improve the patients' awareness of DKD, regularly screen early kidney diseases and use drugs rationally.
In order to promote the standardization of diagnosis and treatment of patients with DKD, improve the knowledge and screening rate of patients with DKD, help the formation of health literacy, healthy behavior and lifestyle, the investigators planned the study.
STUDY OBJECTIVES:
- To understand the epidemiological disease burden of DKD in China, and to investigate the prevalence rate, awareness rate and screening rate of DKD;
- To understand the treatment status of patients with DKD in China;
- To provide real-world data on the efficacy and safety of SGLT2i in the treatment of DKD in China;
研究の種類
観察的
入学 (予想される)
10000
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Beijing、中国
- The 8th Medical Center of Chinese Pla General Hospital
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Beijing、中国
- Airport Area of Peking University Third Hospital
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Beijing、中国
- Beijing Haidian Hospital
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Beijing、中国
- Beijing Luhe Hospital, Capital Medical University
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Beijing、中国
- Peking University Third Hospital YanQing Hospital
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Beijing、中国
- Peking University Third Hospital
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Beijing、中国
- Strategic Support Force Specialty Medical Center
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Beijing、中国
- The 3th Medical Center of Chinese PLA General Hospital
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Beijing、中国
- The 4th Medical Center of Chinese PLA General Hospital
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Beijing、中国
- The 5th Medical Center of Chinese PLA General Hospital
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Beijing、中国
- The 6th Medical Center of Chinese PLA General Hospital
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Beijing、中国
- The 7th Medical Center of Chinese PLA General Hospital
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Beijing、中国
- The First Medical Center of Chinese PLA General Hospital
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Guangzhou、中国
- Guangdong Provincial People's Hospital
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Guangzhou、中国
- Guangzhou First People's Hospital
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Guangzhou、中国
- Guangzhou red cross hospital
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Guangzhou、中国
- Nanfang Hospital, Southern Medical University
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Guangzhou、中国
- Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
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Guiyang、中国
- The Affiliated Hospital of Guizhou Medical University
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Guiyang、中国
- Guiyang First People's Hospital
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Guiyang、中国
- Guiyang Second People's Hospital
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Guiyang、中国
- The Second Affiliated Hospital Of Guizhou Medical University
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Hefei、中国
- The First Affiliated Hospital of Anhui Medical University
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Nanjin、中国
- NanjingNanjing Drum Tower Hospital( the Affiliated Hospital of Nanjing University Medical School)
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Nanjing、中国
- Nanjing First Hospital
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Nantong、中国
- Nantong First People's Hospital
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Qingdao、中国
- Qingdao Eighth People's Hospital
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Qingdao、中国
- Qingdao Third People's Hospital
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Qingdao、中国
- The Affiliated Hospital of Qingdao University
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Rizhao、中国
- People's Hospital of Rizhao
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Shanghai、中国
- Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University
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Shanghai、中国
- Shanghai Minhang District Central Hospital
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Shanghai、中国
- Shanghai Xuhui District Central Hospital
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Shanghai、中国
- Wusong Hospital, Zhongshan Hospital affiliated to Fudan University
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Shanghai、中国
- Zhongshan Hospital Affiliated to Fudan University
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Suzhou、中国
- Second Affiliated Hospital of Soochow University
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Suzhou、中国
- The First Affiliated Hospital Of Soochow University
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Taizhou、中国
- Taizhou Second People's Hospita
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Weihai、中国
- Weihai Municipal Hospital
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Wuhan、中国
- Renmin Hospital of Wuhan University
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Wuhan、中国
- The Central Hospital of Wuhan
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Wuhan、中国
- Tongji Hospital, Tongji Medical College of HUST
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Wuhan、中国
- Wuhan No. 1 Hospital
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Wuhan、中国
- Wuhan No. 3 Hospital
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Wuhan、中国
- Wuhan No. 4 Hospital
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Xuzhou、中国
- The Affiliated Hospital of Xuzhou Medical University
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Yixing、中国
- Yixing People's Hospital
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Zhenjiang、中国
- Zhenjiang First People's Hospital
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Zunyi、中国
- The Affiliated Hospital of Zunyi Medical University
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Zunyi、中国
- Zunyi First People's Hospital
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
確率サンプル
調査対象母集団
Continuous screening of type 2 diabetic patients from the endocrinology outpatients of 50 hospitals across the country
説明
Inclusion Criteria:
- It is known that patients with T2DM has a history of more than 12 months (the WHO1999 Standard) and is treated with at least one anti-diabetic agent.
- Gender and age: men and women who are at least 18 years old with informed consent.
- Patients are willing and able to provide written informed consent before participating in this study.
Exclusion Criteria:
- Type 1 diabetes mellitus (DM)
- Patients with severe ketosis, diabetic coma, severe infection or severe trauma
- Perioperative patients
- Patients with severe renal impairment and advanced nephropathy (eGFR < 45 ml/min/1.73m2)
- Renal transplant patients
- Patients are participating in or have participated in any other clinical trials in the past 3 months
- Any disease with a life expectancy of less than 2 years according to the clinical judgment of the investigator
- Pregnant or lactating women
- Patients judged by the investigator to be unsuitable for participating in the study.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：コホート
- 時間の展望：見込みのある
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Prevalence of DKD
時間枠：at the time of screening
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Prevalence of DKD (UACR > 30 mg/g); The prevalence of microalbuminuria (30 mg/g ≤ UACR ≤ 300 mg/g); The prevalence of massive proteinuria (UACR > 300 mg/g).
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at the time of screening
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Awareness rate
時間枠：at the time of screening
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Awareness rate=(The number of people who know their abnormal albuminuria)/(The number of people with diabetes mellitus complicated with albuminuria)
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at the time of screening
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Screening rate
時間枠：at the time of screening
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Screening rate=(The number of people @who have checked urine protein within one year)/(The number of people involved in total diabetes)
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at the time of screening
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Prescription proportion of various anti-diabetic drugs for patients with DKD
時間枠：at the time of screening
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Prescription ratio of a certain hypoglycemic agent =(The number of people using a certain hypoglycemic agent)/(Total number of DKD)
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at the time of screening
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risk factors of albuminuria: medication categories
時間枠：at the time of screening
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Assess whether taking different categories of medications is a risk factor for albuminuria
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at the time of screening
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risk factors of albuminuria: Course of disease
時間枠：at the time of screening
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It is defined as the years of diagnosis of diabetes.
According to the "Date of Diagnosis" in the questionnaire collected during the screening, the course years of diabetes patients are divided into quartiles for evaluation
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at the time of screening
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risk factors of albuminuria: Age
時間枠：at the time of screening
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According to the "date of birth" in the questionnaire collected during the screening, the age of diabetic patients is divided into quartiles for evaluation
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at the time of screening
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risk factors of albuminuria: Current smoking
時間枠：at the time of screening
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According to the "Current smoking" in the questionnaire collected during the screening to evaluate whether smoking is the risk of albuminuria
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at the time of screening
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risk factors of albuminuria: gender
時間枠：at the time of screening
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According to the "gender" in the questionnaire collected during the screening to evaluate whether gender is the risk of albuminuria
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at the time of screening
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risk factors of albuminuria: Drinking
時間枠：at the time of screening
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According to the " Drinking " in the questionnaire collected during the screening to evaluate whether Drinking is the risk of albuminuria
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at the time of screening
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risk factors of albuminuria: Glycosylated hemoglobin
時間枠：at baseline
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Baseline glycosylated hemoglobin is divided into quartiles for evaluation
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at baseline
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risk factors of albuminuria: Hypertension
時間枠：at baseline
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It is defined as the adults' systolic blood pressure which is greater than or equal to 140mmHg and/or diastolic blood pressure which is greater than or equal to 90mmHg.
"hypertension" and "non-hypertension" for evaluation
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at baseline
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risk factors of albuminuria: Increase in Low density lipoprotein cholesterol (LDL-C)
時間枠：at baseline
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It is defined as more than 3.37mmol/L, "elevated" and "normal" for evaluation
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at baseline
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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MD of the change of UACR
時間枠：at 6 months
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the mean difference of the change of UACR from baseline between SGLT2i and non-SGLT2i group
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at 6 months
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OR of the incidence of the adverse events
時間枠：at 6 months
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the odds ratio of the incidence of the adverse events of interest during the 6-month observation period between SGLT2i and non-SGLT2i group
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at 6 months
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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MD of the Percentage change of HbA1c
時間枠：at 6 months
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the mean difference of the Percentage change from baseline of HbA1c between SGLT2i group and non-SGLT2i group
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at 6 months
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MD the Percentage change from baseline of other laboratory test parameters of interest
時間枠：at 6 months
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the mean difference of the Percentage change from baseline of other laboratory test parameters of interest in SGLT2i group and non-SGLT2i group
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at 6 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Yimin Mu, MD、The First Medical Center of Chinese PLA General Hospital
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Wen CP, Chang CH, Tsai MK, Lee JH, Lu PJ, Tsai SP, Wen C, Chen CH, Kao CW, Tsao CK, Wu X. Diabetes with early kidney involvement may shorten life expectancy by 16 years. Kidney Int. 2017 Aug;92(2):388-396. doi: 10.1016/j.kint.2017.01.030. Epub 2017 Jun 1.
- Zinman B, Wanner C, Lachin JM, Fitchett D, Bluhmki E, Hantel S, Mattheus M, Devins T, Johansen OE, Woerle HJ, Broedl UC, Inzucchi SE; EMPA-REG OUTCOME Investigators. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015 Nov 26;373(22):2117-28. doi: 10.1056/NEJMoa1504720. Epub 2015 Sep 17.
- Neal B, Perkovic V, Mahaffey KW, de Zeeuw D, Fulcher G, Erondu N, Shaw W, Law G, Desai M, Matthews DR; CANVAS Program Collaborative Group. Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes. N Engl J Med. 2017 Aug 17;377(7):644-657. doi: 10.1056/NEJMoa1611925. Epub 2017 Jun 12.
- Wiviott SD, Raz I, Bonaca MP, Mosenzon O, Kato ET, Cahn A, Silverman MG, Zelniker TA, Kuder JF, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Ruff CT, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Langkilde AM, Sabatine MS; DECLARE-TIMI 58 Investigators. Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2019 Jan 24;380(4):347-357. doi: 10.1056/NEJMoa1812389. Epub 2018 Nov 10.
- Perkovic V, Jardine MJ, Neal B, Bompoint S, Heerspink HJL, Charytan DM, Edwards R, Agarwal R, Bakris G, Bull S, Cannon CP, Capuano G, Chu PL, de Zeeuw D, Greene T, Levin A, Pollock C, Wheeler DC, Yavin Y, Zhang H, Zinman B, Meininger G, Brenner BM, Mahaffey KW; CREDENCE Trial Investigators. Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy. N Engl J Med. 2019 Jun 13;380(24):2295-2306. doi: 10.1056/NEJMoa1811744. Epub 2019 Apr 14.
- Cannon CP, Pratley R, Dagogo-Jack S, Mancuso J, Huyck S, Masiukiewicz U, Charbonnel B, Frederich R, Gallo S, Cosentino F, Shih WJ, Gantz I, Terra SG, Cherney DZI, McGuire DK; VERTIS CV Investigators. Cardiovascular Outcomes with Ertugliflozin in Type 2 Diabetes. N Engl J Med. 2020 Oct 8;383(15):1425-1435. doi: 10.1056/NEJMoa2004967. Epub 2020 Sep 23.
- McMurray JJV, Solomon SD, Inzucchi SE, Kober L, Kosiborod MN, Martinez FA, Ponikowski P, Sabatine MS, Anand IS, Belohlavek J, Bohm M, Chiang CE, Chopra VK, de Boer RA, Desai AS, Diez M, Drozdz J, Dukat A, Ge J, Howlett JG, Katova T, Kitakaze M, Ljungman CEA, Merkely B, Nicolau JC, O'Meara E, Petrie MC, Vinh PN, Schou M, Tereshchenko S, Verma S, Held C, DeMets DL, Docherty KF, Jhund PS, Bengtsson O, Sjostrand M, Langkilde AM; DAPA-HF Trial Committees and Investigators. Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2019 Nov 21;381(21):1995-2008. doi: 10.1056/NEJMoa1911303. Epub 2019 Sep 19.
- Bailey CJ, Gross JL, Hennicken D, Iqbal N, Mansfield TA, List JF. Dapagliflozin add-on to metformin in type 2 diabetes inadequately controlled with metformin: a randomized, double-blind, placebo-controlled 102-week trial. BMC Med. 2013 Feb 20;11:43. doi: 10.1186/1741-7015-11-43. Erratum In: BMC Med. 2013;11:193.
- Strojek K, Yoon KH, Hruba V, Elze M, Langkilde AM, Parikh S. Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with glimepiride: a randomized, 24-week, double-blind, placebo-controlled trial. Diabetes Obes Metab. 2011 Oct;13(10):928-38. doi: 10.1111/j.1463-1326.2011.01434.x.
- Guo K, Zhang L, Zhao F, Lu J, Pan P, Yu H, Bao Y, Chen H, Jia W. Prevalence of chronic kidney disease and associated factors in Chinese individuals with type 2 diabetes: Cross-sectional study. J Diabetes Complications. 2016 Jul;30(5):803-10. doi: 10.1016/j.jdiacomp.2016.03.020. Epub 2016 Mar 17.
- Shikata K, Kodera R, Utsunomiya K, Koya D, Nishimura R, Miyamoto S, Tajima N; JDCP study group. Prevalence of albuminuria and renal dysfunction, and related clinical factors in Japanese patients with diabetes: The Japan Diabetes Complication and its Prevention prospective study 5. J Diabetes Investig. 2020 Mar;11(2):325-332. doi: 10.1111/jdi.13116. Epub 2019 Sep 25.
- Mok KY, Chan PF, Lai LKP, Chow KL, Chao DVK. Prevalence of diabetic nephropathy among Chinese patients with type 2 diabetes mellitus and different categories of their estimated glomerular filtration rate based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation in primary care in Hong Kong: a cross-sectional study. J Diabetes Metab Disord. 2019 Nov 15;18(2):281-288. doi: 10.1007/s40200-018-00382-y. eCollection 2019 Dec.
- Jitraknatee J, Ruengorn C, Nochaiwong S. Prevalence and Risk Factors of Chronic Kidney Disease among Type 2 Diabetes Patients: A Cross-Sectional Study in Primary Care Practice. Sci Rep. 2020 Apr 10;10(1):6205. doi: 10.1038/s41598-020-63443-4.
- Pollock C, Stefansson B, Reyner D, Rossing P, Sjostrom CD, Wheeler DC, Langkilde AM, Heerspink HJL. Albuminuria-lowering effect of dapagliflozin alone and in combination with saxagliptin and effect of dapagliflozin and saxagliptin on glycaemic control in patients with type 2 diabetes and chronic kidney disease (DELIGHT): a randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2019 Jun;7(6):429-441. doi: 10.1016/S2213-8587(19)30086-5. Epub 2019 Apr 13.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2021年12月25日
一次修了 (予想される)
2023年5月1日
研究の完了 (予想される)
2023年6月1日
試験登録日
最初に提出
2021年9月3日
QC基準を満たした最初の提出物
2021年9月11日
最初の投稿 (実際)
2021年9月17日
学習記録の更新
投稿された最後の更新 (実際)
2022年5月27日
QC基準を満たした最後の更新が送信されました
2022年5月23日
最終確認日
2022年5月1日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
De-identified individual participant level data and measurements including tables, figures, and appendices or supplementary material that support the results presented in a manuscript will be shared 6 months after publication.
IPD 共有時間枠
starting 6 months after publication
IPD 共有アクセス基準
Researches should send a proposal to muyiming@301hospital.com.cn.
If the proposal is methodologically sound, feasible and approved by the principal investigator, data requestor could gain access after signing a data access agreement.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
糖尿病性腎症の臨床試験
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