To Improve the Ability of Early Screening and Diagnosis in Patients With Diabetic Nephropathy
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
1 other identifier
observational
10,000
1 country
50
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2021
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 3, 2021
CompletedFirst Posted
Study publicly available on registry
September 17, 2021
CompletedStudy Start
First participant enrolled
December 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedMay 27, 2022
May 1, 2022
1.3 years
September 3, 2021
May 23, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (13)
Prevalence of DKD
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).
at the time of screening
Awareness rate
Awareness rate=(The number of people who know their abnormal albuminuria)/(The number of people with diabetes mellitus complicated with albuminuria)
at the time of screening
Screening rate
Screening rate=(The number of people @who have checked urine protein within one year)/(The number of people involved in total diabetes)
at the time of screening
Prescription proportion of various anti-diabetic drugs for patients with DKD
Prescription ratio of a certain hypoglycemic agent =(The number of people using a certain hypoglycemic agent)/(Total number of DKD)
at the time of screening
risk factors of albuminuria: medication categories
Assess whether taking different categories of medications is a risk factor for albuminuria
at the time of screening
risk factors of albuminuria: Course of disease
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
at the time of screening
risk factors of albuminuria: Age
According to the "date of birth" in the questionnaire collected during the screening, the age of diabetic patients is divided into quartiles for evaluation
at the time of screening
risk factors of albuminuria: Current smoking
According to the "Current smoking" in the questionnaire collected during the screening to evaluate whether smoking is the risk of albuminuria
at the time of screening
risk factors of albuminuria: gender
According to the "gender" in the questionnaire collected during the screening to evaluate whether gender is the risk of albuminuria
at the time of screening
risk factors of albuminuria: Drinking
According to the " Drinking " in the questionnaire collected during the screening to evaluate whether Drinking is the risk of albuminuria
at the time of screening
risk factors of albuminuria: Glycosylated hemoglobin
Baseline glycosylated hemoglobin is divided into quartiles for evaluation
at baseline
risk factors of albuminuria: Hypertension
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
at baseline
risk factors of albuminuria: Increase in Low density lipoprotein cholesterol (LDL-C)
It is defined as more than 3.37mmol/L, "elevated" and "normal" for evaluation
at baseline
Secondary Outcomes (2)
MD of the change of UACR
at 6 months
OR of the incidence of the adverse events
at 6 months
Other Outcomes (2)
MD of the Percentage change of HbA1c
at 6 months
MD the Percentage change from baseline of other laboratory test parameters of interest
at 6 months
Eligibility Criteria
Continuous screening of type 2 diabetic patients from the endocrinology outpatients of 50 hospitals across the country
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yiming Mulead
Study Sites (50)
Airport Area of Peking University Third Hospital
Beijing, China
Beijing Haidian Hospital
Beijing, China
Beijing Luhe Hospital, Capital Medical University
Beijing, China
Peking University Third Hospital Yanqing Hospital
Beijing, China
Peking University Third Hospital
Beijing, China
Strategic Support Force Specialty Medical Center
Beijing, China
The 3th Medical Center of Chinese PLA General Hospital
Beijing, China
The 4th Medical Center of Chinese PLA General Hospital
Beijing, China
The 5th Medical Center of Chinese PLA General Hospital
Beijing, China
The 6th Medical Center of Chinese PLA General Hospital
Beijing, China
The 7th Medical Center of Chinese PLA General Hospital
Beijing, China
The 8th Medical Center of Chinese PLA General Hospital
Beijing, China
The First Medical Center of Chinese PLA General Hospital
Beijing, China
Guangdong Provincial People's Hospital
Guangzhou, China
Guangzhou First People's Hospital
Guangzhou, China
Guangzhou Red Cross Hospital
Guangzhou, China
Nanfang Hospital, Southern Medical University
Guangzhou, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China
Guiyang First People's Hospital
Guiyang, China
Guiyang Second People's Hospital
Guiyang, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, China
The Second Affiliated Hospital of Guizhou Medical University
Guiyang, China
The First Affiliated Hospital of Anhui Medical University
Hefei, China
NanjingNanjing Drum Tower Hospital( the Affiliated Hospital of Nanjing University Medical School)
Nanjin, China
Nanjing First Hospital
Nanjing, China
Nantong First People's Hospital
Nantong, China
Qingdao Eighth People's Hospital
Qingdao, China
Qingdao Third People's Hospital
Qingdao, China
The Affiliated Hospital of Qingdao University
Qingdao, China
People's Hospital of Rizhao
Rizhao, China
Qingpu Branch of Zhongshan Hospital affiliated to Fudan University
Shanghai, China
Shanghai Minhang District Central Hospital
Shanghai, China
Shanghai Xuhui District Central Hospital
Shanghai, China
Wusong Hospital, Zhongshan Hospital affiliated to Fudan University
Shanghai, China
Zhongshan Hospital affiliated to Fudan University
Shanghai, China
Second Affiliated Hospital of Soochow University
Suzhou, China
The First Affiliated Hospital of Soochow University
Suzhou, China
Taizhou Second People's Hospita
Taizhou, China
Weihai Municipal Hospital
Weihai, China
Renmin Hospital of Wuhan University
Wuhan, China
The Central Hospital of Wuhan
Wuhan, China
Tongji Hospital, Tongji Medical College Of HUST
Wuhan, China
Wuhan No. 1 Hospital
Wuhan, China
Wuhan No. 3 Hospital
Wuhan, China
Wuhan No. 4 Hospital
Wuhan, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, China
Yixing People's Hospital
Yixing, China
Zhenjiang First People's Hospital
Zhenjiang, China
The Affiliated Hospital of Zunyi Medical University
Zunyi, China
Zunyi First People's Hospital
Zunyi, China
Related Publications (15)
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.
PMID: 28577854BACKGROUNDZinman 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.
PMID: 26378978BACKGROUNDNeal 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.
PMID: 28605608BACKGROUNDWiviott 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.
PMID: 30415602BACKGROUNDPerkovic 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.
PMID: 30990260BACKGROUNDCannon 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.
PMID: 32966714BACKGROUNDMcMurray 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.
PMID: 31535829BACKGROUNDBailey 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.
PMID: 23425012BACKGROUNDStrojek 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.
PMID: 21672123BACKGROUNDGuo 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.
PMID: 27068269BACKGROUNDShikata 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.
PMID: 31317670BACKGROUNDMok 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.
PMID: 31890652BACKGROUNDJitraknatee 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.
PMID: 32277150BACKGROUNDPollock 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.
PMID: 30992195BACKGROUNDShi L, Xue Y, Yu X, Wang Y, Hong T, Li X, Ma J, Zhu D, Mu Y. Prevalence and Risk Factors of Chronic Kidney Disease in Patients With Type 2 Diabetes in China: Cross-Sectional Study. JMIR Public Health Surveill. 2024 Aug 30;10:e54429. doi: 10.2196/54429.
PMID: 39213031DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yimin Mu, MD
The First Medical Center of Chinese PLA General Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director of department
Study Record Dates
First Submitted
September 3, 2021
First Posted
September 17, 2021
Study Start
December 25, 2021
Primary Completion
May 1, 2023
Study Completion
June 1, 2023
Last Updated
May 27, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- starting 6 months after publication
- Access Criteria
- 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.
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.