Diabetic Kidney Disease
Conditions
Keywords
SGLT2 inhibitors, Diabetic Kidney Disease, Albuminuria
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;
Interventions
None listed
Sponsors
Yiming Mu
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| risk factors of albuminuria: Increase in Low density lipoprotein cholesterol (LDL-C) | at baseline | It is defined as more than 3.37mmol/L, elevated and normal for evaluation |
| risk factors of albuminuria: gender | 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 |
| risk factors of albuminuria: Drinking | 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 |
| risk factors of albuminuria: Glycosylated hemoglobin | at baseline | Baseline glycosylated hemoglobin is divided into quartiles for evaluation |
| risk factors of albuminuria: Hypertension | 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 |
| Prevalence of DKD | 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). |
| Awareness rate | 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) |
| Screening rate | 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) |
| Prescription proportion of various anti-diabetic drugs for patients with DKD | 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) |
| risk factors of albuminuria: medication categories | at the time of screening | Assess whether taking different categories of medications is a risk factor for albuminuria |
| risk factors of albuminuria: Course of disease | 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 |
| risk factors of albuminuria: Age | 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 |
| risk factors of albuminuria: Current smoking | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MD of the change of UACR | at 6 months | the mean difference of the change of UACR from baseline between SGLT2i and non-SGLT2i group |
| OR of the incidence of the adverse events | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| MD the Percentage change from baseline of other laboratory test parameters of interest | 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 |
| MD of the Percentage change of HbA1c | at 6 months | the mean difference of the Percentage change from baseline of HbA1c between SGLT2i group and non-SGLT2i group |
Countries
China
Outcome results
None listed