Diabetic Kidney Disease (DKD)
Conditions
Brief summary
In order to reduce the clinical demand for kidney dialysis rate of Diabetic Kidney Disease（DKD） patients, a bidirectional cohort study of 4472 patients with DKD (Qi deficiency and collateral stasis syndrome) was carried out based on a preliminary DKD cohort of 13,000 patients. The exposure factor was supplementing and reducing the kidney turbidity-Huoxue Tongluo method represented by the addition and subversion of Shenzhuo prescription, and the incidence of end-stage renal disease was the main therapeutic index. Follow-up was conducted for 2 years
Interventions
None listed
Sponsors
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
First Affiliated Hospital, Sun Yat-Sen University
Tianjin Medical University Chu Hsien-I Memorial Hospital
Changchun University of Chinese Medicine
EFONG PHARMRCEUTICRL
Xinxiang Central Hospital of Henan province
Xiamen Hospital of Traditional Chinese Medicine
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Beijing Tiantan Hospital
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
Hubei Zhongshan Hospital Affiliated to Wuhan University
Liu Hongfang
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 1 in line with Western medicine diagnostic criteria for type 2 diabetic kidney disease ; * 2 18-80 years old, regardless of gender ; * 3 eGFR \> 15ml / ( min · 1.73m2 ) ; the eGFR was calculated according to the chronic kidney disease epidemiology collaboration equation ( CKD-EPI ). * 4 In line with the diagnostic criteria of qi deficiency and collateral stasis syndrome in traditional Chinese medicine ; * 5glycosylated hemoglobin ( HbA1c ) between 7-10 % ; * 6 blood pressure ≤ 160 / 100mmHg ; * 7 to sign the informed consent ;
Exclusion criteria
* 1 combined with other clear renal diseases, such as polycystic kidney disease, glomerulonephritis, renal tumor, etc. ; * 2 patients with a history of recurrent genitourinary tract infection ; * 3 combined with cardiovascular and cerebrovascular, digestive, respiratory, urinary, immune system serious diseases or mental diseases ; * 4 currently in pregnancy, lactation, or pregnancy plan women ; * 5 Patients with type 1 diabetes. * 6 Tumor patients undergoing radiotherapy, chemotherapy or targeted therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of end-stage renal disease | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years | dialysis, transplantation or glomerular filtration rate ( eGFR ) \< 15ml / ( min · 1.73m2 ) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of renal composite outcome indicators | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years | End-stage renal disease \[ dialysis, transplantation or glomerular filtration rate ( eGFR ) \< 15ml / ( min · 1.73m2 ) \], eGFR decreased by more than 50 %, renal causes of death were defined. |
| Changes of urinary protein creatinine ratio | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years | Changes of urinary protein creatinine ratio |
| Changes of 24-hour urinary protein level | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years | Changes of 24-hour urinary protein level |
| Estimate the change value of glomerular filtration rate ( eGFR ) level, slope | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years | Estimate the change value of glomerular filtration rate ( eGFR ) level, slope |
| Chinese medicine syndrome scores | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years | The TCM（Traditional Chinese Medicine） symptoms of the patients were scored by the TCM syndrome scale in order to judge the improvement of their symptoms.The highest score was 114 points, and the lowest score was 0 points. The higher the score, the worse the patient 's health. |
Other
| Measure | Time frame | Description |
|---|---|---|
| glycosylated hemoglobin | Review period, enrollment, enrollment after two months, enrollment after half a year, enrollment after 1 year, enrollment after 1 and a half years, enrollment after two years | glycosylated hemoglobin |
| fasting blood glucose | Review period, enrollment, enrollment after two months, enrollment after half a year, enrollment after 1 year, enrollment after 1 and a half years, enrollment after two years | fasting blood glucose |
| incidence of adverse events | Review period, enrollment, enrollment after two months, enrollment after half a year, enrollment after 1 year, enrollment after 1 and a half years, enrollment after two years | incidence of adverse events |
| Number of participants with abnormal red blood cell count ( RBC ) | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years | Number of participants with abnormal red blood cell count ( RBC ) |
| Number of participants with abnormal hemoglobin ( HGB ) | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years | Number of participants with abnormal hemoglobin ( HGB ) |
| Number of participants with abnormal lymphocyte percentage ( LY % ) | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years | Number of participants with abnormal lymphocyte percentage ( LY % ) |
| Number of participants with abnormal Percentage of neutrophils( NE % ) | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years | Number of participants with abnormal Percentage of neutrophils( NE % ) |
| Number of participants with abnormal Platelet count ( PLT ) | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years | Number of participants with abnormal Platelet count ( PLT ) |
| Number of participants with abnormal Urine PH value | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years | Number of participants with abnormal Urine PH value |
| Number of participants with abnormal Urinary protein | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years | Number of participants with abnormal Urinary protein |
| Number of participants with abnormal Urine occult blood | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years | Number of participants with abnormal Urine occult blood |
| Number of participants with abnormal Urinary glucose | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years | Number of participants with abnormal Urinary glucose |
| Number of participants with abnormal Urine ketone | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years | Number of participants with abnormal Urine ketone |
| Number of participants with abnormal Urine white blood cells (high magnification field of view) | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years | Number of participants with abnormal Urine white blood cells (high magnification field of view) |
| Number of participants with abnormal Urine red blood cells (high magnification field of view) | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years | Number of participants with abnormal Urine red blood cells (high magnification field of view) |
| Number of participants with abnormal Serum alanine aminotransferase | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years | Number of participants with abnormal Serum alanine aminotransferase |
| Number of participants with abnormal Serum aspartate aminotransferase | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years | Number of participants with abnormal Serum aspartate aminotransferase |
| Number of participants with abnormal Serum alkaline phosphatase | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years | Number of participants with abnormal Serum alkaline phosphatase |
| Number of participants with abnormal Serum gamma-glutamyl transferase | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years | Number of participants with abnormal Serum gamma-glutamyl transferase |
| Number of participants with abnormal Serum albumin (ALB) | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years | Number of participants with abnormal Serum albumin (ALB) |
| Body temperature | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years | Body temperature |
| Number of participants with abnormal Serum direct bilirubin（DBIL） | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years | Number of participants with abnormal Serum direct bilirubin（DBIL） |
| Number of participants with abnormal Serum indirect bilirubin（IBIL） | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years | Number of participants with abnormal Serum indirect bilirubin（IBIL） |
| Serum urea | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years | Serum urea |
| Serum urate | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years | Serum urate |
| Serum cystatin C | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years | Serum cystatin C |
| Serum creatinine | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years | Serum creatinine |
| Plasma triglyceride | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years | Plasma triglyceride |
| Plasma high-density lipoprotein | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years | Plasma high-density lipoprotein |
| Plasma total cholesterol | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years | Plasma total cholesterol |
| Plasma low-density lipoprotein | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years | Plasma low-density lipoprotein |
| Number of participants with abnormal Serum total bilirubin（TBIL） | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years | Number of participants with abnormal Serum total bilirubin（TBIL） |
| blood pressure | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years | Both systolic and diastolic blood pressures should be measured. |
| respiration | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years. | respiration |
| heart rate | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years | heart rate |
| Number of participants with abnormal white blood cell count ( WBC ) | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years | Number of participants with abnormal white blood cell count ( WBC ) |
| Number of participants with abnormal electrocardiogram | Review period, enrollment, enrollment after two months, enrollment after half a year, enrollment after 1 year, enrollment after 1 and a half years, enrollment after two years | Number of participants with abnormal electrocardiogram |
Countries
China
Contacts
Primary ContactQingqing Liu
Backup ContactFengyi Cai
Outcome results
None listed