Clinical trial NCT05047471: To Improve the Ability of Early Screening and Diagnosis in Patients With Diabetic Nephropathy
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Kidney Disease
Keywords: SGLT2 inhibitors
Diabetic Kidney Disease
Albuminuria
Lead sponsor: Beijing Great Physician Commonweal Foundation
Sponsor class: OTHER
First posted: 2021-09-17
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Continuous screening of type 2 diabetic patients from the endocrinology outpatients of 50 hospitals across the country

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).

Detailed description: 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:

1. To understand the epidemiological disease burden of DKD in China, and to investigate the prevalence rate, awareness rate and screening rate of DKD;
2. To understand the treatment status of patients with DKD in China;
3. To provide real-world data on the efficacy and safety of SGLT2i in the treatment of DKD in China;

Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of DKD
timeFrame: at the time of screening
measure: Awareness rate
timeFrame: at the time of screening
measure: Screening rate
timeFrame: at the time of screening
measure: Prescription proportion of various anti-diabetic drugs for patients with DKD
timeFrame: at the time of screening
measure: risk factors of albuminuria: medication categories
timeFrame: at the time of screening
measure: risk factors of albuminuria: Course of disease
timeFrame: at the time of screening
measure: risk factors of albuminuria: Age
timeFrame: at the time of screening
measure: risk factors of albuminuria: Current smoking
timeFrame: at the time of screening
measure: risk factors of albuminuria: gender
timeFrame: at the time of screening
measure: risk factors of albuminuria: Drinking
timeFrame: at the time of screening
measure: risk factors of albuminuria: Glycosylated hemoglobin
timeFrame: at baseline
measure: risk factors of albuminuria: Hypertension
timeFrame: at baseline
measure: risk factors of albuminuria: Increase in Low density lipoprotein cholesterol (LDL-C)
timeFrame: at baseline
Secondary outcomes:
measure: MD of the change of UACR
timeFrame: at 6 months
measure: OR of the incidence of the adverse events
timeFrame: at 6 months
Other outcomes:
measure: MD of the Percentage change of HbA1c
timeFrame: at 6 months
measure: MD the Percentage change from baseline of other laboratory test parameters of interest
timeFrame: at 6 months
Locations:
city: Beijing
country: China
facility: Airport Area of Peking University Third Hospital
city: Beijing
country: China
facility: Beijing Haidian Hospital
city: Beijing
country: China
facility: Beijing Luhe Hospital, Capital Medical University
city: Beijing
country: China
facility: Peking University Third Hospital Yanqing Hospital
city: Beijing
country: China
facility: Peking University Third Hospital
city: Beijing
country: China
facility: Strategic Support Force Specialty Medical Center
city: Beijing
country: China
facility: The 3th Medical Center of Chinese PLA General Hospital
city: Beijing
country: China
facility: The 4th Medical Center of Chinese PLA General Hospital
city: Beijing
country: China
facility: The 5th Medical Center of Chinese PLA General Hospital
city: Beijing
country: China
facility: The 6th Medical Center of Chinese PLA General Hospital
city: Beijing
country: China
facility: The 7th Medical Center of Chinese PLA General Hospital
city: Beijing
country: China
facility: The 8th Medical Center of Chinese PLA General Hospital
city: Beijing
country: China
facility: The First Medical Center of Chinese PLA General Hospital
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
city: Guangzhou
country: China
facility: Guangzhou Red Cross Hospital
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
city: Guiyang
country: China
facility: Guiyang First People's Hospital
city: Guiyang
country: China
facility: Guiyang Second People's Hospital
city: Guiyang
country: China
facility: The Affiliated Hospital of Guizhou Medical University
city: Guiyang
country: China
facility: The Second Affiliated Hospital of Guizhou Medical University
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
city: Nanjing
country: China
facility: Nanjing First Hospital
city: Nanjin
country: China
facility: NanjingNanjing Drum Tower Hospital( the Affiliated Hospital of Nanjing University Medical School)
city: Nantong
country: China
facility: Nantong First People's Hospital
city: Qingdao
country: China
facility: Qingdao Eighth People's Hospital
city: Qingdao
country: China
facility: Qingdao Third People's Hospital
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
city: Rizhao
country: China
facility: People's Hospital of Rizhao
city: Shanghai
country: China
facility: Qingpu Branch of Zhongshan Hospital affiliated to Fudan University
city: Shanghai
country: China
facility: Shanghai Minhang District Central Hospital
city: Shanghai
country: China
facility: Shanghai Xuhui District Central Hospital
city: Shanghai
country: China
facility: Wusong Hospital, Zhongshan Hospital affiliated to Fudan University
city: Shanghai
country: China
facility: Zhongshan Hospital affiliated to Fudan University
city: Suzhou
country: China
facility: Second Affiliated Hospital of Soochow University
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
city: Taizhou
country: China
facility: Taizhou Second People's Hospita
city: Weihai
country: China
facility: Weihai Municipal Hospital
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
city: Wuhan
country: China
facility: The Central Hospital of Wuhan
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College Of HUST
city: Wuhan
country: China
facility: Wuhan No. 1 Hospital
city: Wuhan
country: China
facility: Wuhan No. 3 Hospital
city: Wuhan
country: China
facility: Wuhan No. 4 Hospital
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
city: Yixing
country: China
facility: Yixing People's Hospital
city: Zhenjiang
country: China
facility: Zhenjiang First People's Hospital
city: Zunyi
country: China
facility: The Affiliated Hospital of Zunyi Medical University
city: Zunyi
country: China
facility: Zunyi First People's Hospital
Study officials:
affiliation: The First Medical Center of Chinese PLA General Hospital
name: Yimin Mu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.