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Diabetic Kidney DiseaseNCT05047471

To Improve the Ability of Early Screening and Diagnosis in Patients With Diabetic Nephropathy

An observational study of Diabetic Kidney Disease, run by Yiming Mu at 50 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Kidney Disease
How many people
10,000 participants
Where
50 sitesChina
Study dates
25 Dec 2021to Jun 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Continuous screening of type 2 diabetic patients from the endocrinology outpatients of 50 hospitals across the country

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • 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.

Trial locations and contacts

50 sites in 1 country.

50 sites in 1 country

China50 sites

  • Airport Area of Peking University Third Hospital

    Beijing

  • Beijing Haidian Hospital

    Beijing

  • Beijing Luhe Hospital, Capital Medical University

    Beijing

  • Peking University Third Hospital Yanqing Hospital

    Beijing

  • Peking University Third Hospital

    Beijing

  • Strategic Support Force Specialty Medical Center

    Beijing

  • The 3th Medical Center of Chinese PLA General Hospital

    Beijing

  • The 4th Medical Center of Chinese PLA General Hospital

    Beijing

  • The 5th Medical Center of Chinese PLA General Hospital

    Beijing

  • The 6th Medical Center of Chinese PLA General Hospital

    Beijing

  • The 7th Medical Center of Chinese PLA General Hospital

    Beijing

  • The 8th Medical Center of Chinese PLA General Hospital

    Beijing

  • The First Medical Center of Chinese PLA General Hospital

    Beijing

  • Guangdong Provincial People's Hospital

    Guangzhou

  • Guangzhou First People's Hospital

    Guangzhou

  • Guangzhou Red Cross Hospital

    Guangzhou

  • Nanfang Hospital, Southern Medical University

    Guangzhou

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou

  • Guiyang First People's Hospital

    Guiyang

  • Guiyang Second People's Hospital

    Guiyang

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang

  • The Second Affiliated Hospital of Guizhou Medical University

    Guiyang

  • The First Affiliated Hospital of Anhui Medical University

    Hefei

  • NanjingNanjing Drum Tower Hospital( the Affiliated Hospital of Nanjing University Medical School)

    Nanjin

  • Nanjing First Hospital

    Nanjing

  • Nantong First People's Hospital

    Nantong

  • Qingdao Eighth People's Hospital

    Qingdao

  • Qingdao Third People's Hospital

    Qingdao

  • The Affiliated Hospital of Qingdao University

    Qingdao

  • People's Hospital of Rizhao

    Rizhao

  • Qingpu Branch of Zhongshan Hospital affiliated to Fudan University

    Shanghai

  • Shanghai Minhang District Central Hospital

    Shanghai

  • Shanghai Xuhui District Central Hospital

    Shanghai

  • Wusong Hospital, Zhongshan Hospital affiliated to Fudan University

    Shanghai

  • Zhongshan Hospital affiliated to Fudan University

    Shanghai

  • Second Affiliated Hospital of Soochow University

    Suzhou

  • The First Affiliated Hospital of Soochow University

    Suzhou

  • Taizhou Second People's Hospita

    Taizhou

  • Weihai Municipal Hospital

    Weihai

  • Renmin Hospital of Wuhan University

    Wuhan

  • The Central Hospital of Wuhan

    Wuhan

  • Tongji Hospital, Tongji Medical College Of HUST

    Wuhan

  • Wuhan No. 1 Hospital

    Wuhan

  • Wuhan No. 3 Hospital

    Wuhan

  • Wuhan No. 4 Hospital

    Wuhan

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou

  • Yixing People's Hospital

    Yixing

  • Zhenjiang First People's Hospital

    Zhenjiang

  • The Affiliated Hospital of Zunyi Medical University

    Zunyi

  • Zunyi First People's Hospital

    Zunyi

Other trials in China

About this study

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

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).

Read the 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;
Keywords
SGLT2 inhibitors, Diabetic Kidney Disease, Albuminuria
Medical subject headings
Diabetic Nephropathies, Albuminuria

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: at the time of screening

  2. Awareness rate

    Awareness rate=(The number of people who know their abnormal albuminuria)/(The number of people with diabetes mellitus complicated with albuminuria)

    Measured: at the time of screening

  3. Screening rate

    Screening rate=(The number of people @who have checked urine protein within one year)/(The number of people involved in total diabetes)

    Measured: at the time of screening

  4. 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)

    Measured: at the time of screening

  5. risk factors of albuminuria: medication categories

    Assess whether taking different categories of medications is a risk factor for albuminuria

    Measured: at the time of screening

  6. 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

    Measured: at the time of screening

  7. 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

    Measured: at the time of screening

  8. 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

    Measured: at the time of screening

  9. 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

    Measured: at the time of screening

  10. 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

    Measured: at the time of screening

  11. risk factors of albuminuria: Glycosylated hemoglobin

    Baseline glycosylated hemoglobin is divided into quartiles for evaluation

    Measured: at baseline

  12. 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

    Measured: at baseline

  13. 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

    Measured: at baseline

Secondary outcomes (2)

  1. MD of the change of UACR

    the mean difference of the change of UACR from baseline between SGLT2i and non-SGLT2i group

    Measured: at 6 months

  2. OR of the incidence of the adverse events

    the odds ratio of the incidence of the adverse events of interest during the 6-month observation period between SGLT2i and non-SGLT2i group

    Measured: at 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2021
  2. Study start25 Dec 2021
  3. Primary completionMay 2023 (estimated)
  4. Study completionJun 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05047471
Sponsor's protocol ID
2021BY01
Status last verified
May 2022
First submitted
3 Sep 2021
Last updated
27 May 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 28577854

  • 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.

    PubMed 26378978

  • 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.

    PubMed 28605608

  • 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.

    PubMed 30415602

  • 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.

    PubMed 30990260

  • 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.

    PubMed 32966714

  • 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.

    PubMed 31535829

  • 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.

    PubMed 23425012

  • 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.

    PubMed 21672123

  • 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.

    PubMed 27068269

  • 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.

    PubMed 31317670

  • 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.

    PubMed 31890652

  • 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.

    PubMed 32277150

  • 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.

    PubMed 30992195

  • Shi 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.

    PubMed 39213031

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetic Kidney Disease, run by Yiming Mu at 50 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of DKD (time frame: at the time of screening). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05047471, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.

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