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

23 mei 2022 bijgewerkt door: 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).

Studie Overzicht

Toestand

Aanmelden op uitnodiging

Conditie

Gedetailleerde beschrijving

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;

Studietype

Observationeel

Inschrijving (Verwacht)

10000

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • China
      • Beijing, China
        • The 8th Medical Center of Chinese Pla General Hospital
      • Beijing, China
        • 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 First Medical Center of Chinese PLA General Hospital
      • Guangzhou, 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
      • Guiyang, China
        • The Affiliated Hospital of Guizhou Medical University
      • Guiyang, China
        • Guiyang First People's Hospital
      • Guiyang, China
        • Guiyang Second People's Hospital
      • Guiyang, China
        • The Second Affiliated Hospital Of Guizhou Medical University
      • Hefei, China
        • The First Affiliated Hospital of Anhui Medical University
      • Nanjin, China
        • NanjingNanjing Drum Tower Hospital( the Affiliated Hospital of Nanjing University Medical School)
      • Nanjing, China
        • Nanjing First Hospital
      • Nantong, China
        • Nantong First People's Hospital
      • Qingdao, China
        • Qingdao Eighth People's Hospital
      • Qingdao, China
        • Qingdao Third People's Hospital
      • Qingdao, China
        • The Affiliated Hospital of Qingdao University
      • Rizhao, China
        • People's Hospital of Rizhao
      • Shanghai, 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
      • Suzhou, China
        • Second Affiliated Hospital of Soochow University
      • Suzhou, China
        • The First Affiliated Hospital of Soochow University
      • Taizhou, China
        • Taizhou Second People's Hospita
      • Weihai, China
        • Weihai Municipal Hospital
      • Wuhan, 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
      • Xuzhou, China
        • The Affiliated Hospital of Xuzhou Medical University
      • Yixing, China
        • Yixing People's Hospital
      • Zhenjiang, China
        • Zhenjiang First People's Hospital
      • Zunyi, China
        • The Affiliated Hospital of Zunyi Medical University
      • Zunyi, China
        • Zunyi First People's Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

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

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: Cohort
  • Tijdsperspectieven: Prospectief

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Prevalence of DKD
Tijdsspanne: at the time of screening
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
Tijdsspanne: at the time of screening
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
Tijdsspanne: at the time of screening
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
Tijdsspanne: at the time of screening
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
Tijdsspanne: at the time of screening
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
Tijdsspanne: at the time of screening
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
Tijdsspanne: at the time of screening
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
Tijdsspanne: at the time of screening
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
Tijdsspanne: at the time of screening
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
Tijdsspanne: at the time of screening
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
Tijdsspanne: at baseline
Baseline glycosylated hemoglobin is divided into quartiles for evaluation
at baseline
risk factors of albuminuria: Hypertension
Tijdsspanne: at baseline
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)
Tijdsspanne: at baseline
It is defined as more than 3.37mmol/L, "elevated" and "normal" for evaluation
at baseline

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
MD of the change of UACR
Tijdsspanne: at 6 months
the mean difference of the change of UACR from baseline between SGLT2i and non-SGLT2i group
at 6 months
OR of the incidence of the adverse events
Tijdsspanne: at 6 months
the odds ratio of the incidence of the adverse events of interest during the 6-month observation period between SGLT2i and non-SGLT2i group
at 6 months

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
MD of the Percentage change of HbA1c
Tijdsspanne: at 6 months
the mean difference of the Percentage change from baseline of HbA1c between SGLT2i group and non-SGLT2i group
at 6 months
MD the Percentage change from baseline of other laboratory test parameters of interest
Tijdsspanne: at 6 months
the mean difference of the Percentage change from baseline of other laboratory test parameters of interest in SGLT2i group and non-SGLT2i group
at 6 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Yiming Mu

Onderzoekers

  • Hoofdonderzoeker: Yimin Mu, MD, The First Medical Center of Chinese PLA General Hospital

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

25 december 2021

Primaire voltooiing (Verwacht)

1 mei 2023

Studie voltooiing (Verwacht)

1 juni 2023

Studieregistratiedata

Eerst ingediend

3 september 2021

Eerst ingediend dat voldeed aan de QC-criteria

11 september 2021

Eerst geplaatst (Werkelijk)

17 september 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

27 mei 2022

Laatste update ingediend die voldeed aan QC-criteria

23 mei 2022

Laatst geverifieerd

1 mei 2022

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2021BY01

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

Ja

Beschrijving IPD-plan

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-tijdsbestek voor delen

starting 6 months after publication

IPD-toegangscriteria voor delen

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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