Study on accurate diagnosis and treatment of qi deficiency and blood stasis syndrome of diabetes kidney disease and intervention of Shenzhuo recipe based on SNP and uromics

Phase 1

Not yet recruiting

• Conditions: Diabetes and kidney disease

• Registration Number: ITMCTR2200006564
• Lead Sponsor: Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion criteria for healthy people
(1) It meets the diagnostic criteria of healthy people, and the constitution of traditional Chinese medicine is judged to be mild;
(2) Age: 18-70 years old;
(3) Blood glucose is within the normal range;
(4) Those who sign the informed consent form.
Inclusion criteria of qi deficiency and blood stasis syndrome
(1) Those who meet the diagnostic criteria of diabetes nephropathy in traditional Chinese medicine and the syndrome differentiation type is Qi deficiency and blood stasis syndrome, and those who meet the diagnostic criteria of diabetes kidney disease in western medicine and the renal function stage is g2-g3a, and the proteinuria stage is A2-A3.
(2) The fasting blood glucose of the patients is less than 8.0mmol/l, the blood glucose at 2h after meal is less than 11.0mmol/l, and the glycosylated glycemic protein is less than 8.0%, which can be relaxed to 8.5% in the elderly patients.
(3) The patient's blood pressure is not controlled or after taking antihypertensive drugs, the control is greater than 130 / 80mmHg, the diastolic blood pressure is not less than 70mmhg, and the diastolic blood pressure of elderly patients is not less than 60mmhg.
(4) Patients aged 40 years or older and 75 years or younger.
(5) The patient was informed and agreed to participate in this study.
Inclusion criteria of non Qi deficiency and blood stasis syndrome
(1) Those who meet the diagnostic criteria of diabetes nephropathy in traditional Chinese medicine and the syndrome differentiation type is damp heat syndrome, and those who meet the diagnostic criteria of diabetes kidney disease in western medicine and the renal function stage is g2-g3a, and the proteinuria stage is A2-A3.
(2) The fasting blood glucose of the patients is less than 8.0mmol/l, the blood glucose at 2h after meal is less than 11.0mmol/l, and the glycosylated glycemic protein is less than 8.0%, which can be relaxed to 8.5% in the elderly patients.
(3) The patient's blood pressure is not controlled or after taking antihypertensive drugs, the control is greater than 130 / 80mmHg, the diastolic blood pressure is not less than 70mmhg, and the diastolic blood pressure of elderly patients is not less than 60mmhg.
(4) Patients aged 40 years or older and 75 years or younger.
(5) The patient was informed and agreed to participate in this study.

Exclusion Criteria

Exclusion criteria for healthy people
(1) Patients with respiratory system, digestive system, endocrine system, cardiovascular system and other diseases during diagnosis;
(2) Mental patients;
(3) Women who are pregnant, preparing for pregnancy or breastfeeding.
Exclusion criteria of qi deficiency and blood stasis syndrome
(1) Those who do not meet the diagnostic criteria and inclusion criteria of patients with Qi deficiency and blood stasis syndrome;
(2) Patients with type 1 diabetes and kidney disease;
(3) Patients with acute and severe diseases such as diabetes ketosis, ketoacidosis, hyperosmolar coma, and severe infection were not corrected before enrollment;
(4) Patients with severe heart, liver and kidney dysfunction or malignant tumors;
(5) Allergic constitution, patients during pregnancy or lactation, or those who have a history of allergy to various traditional Chinese medicines.
Exclusion criteria of non Qi deficiency and blood stasis syndrome
(1) Those who do not meet the diagnostic criteria and inclusion criteria of damp heat syndrome;
(2) Patients with type 1 diabetes and kidney disease;
(3) Patients with acute and severe diseases such as diabetes ketosis, ketoacidosis, hyperosmolar coma, and severe infection were not corrected before enrollment;
(4) Patients with severe heart, liver and kidney dysfunction or malignant tumors;
(5) Allergic constitution, patients during pregnancy or lactation, or those who have a history of allergy to various traditional Chinese medicines.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SNPs;24h urine protein quantification;Urine Proteomics;Urinary albumin to creatinine ratio;Biochemical full item;glomerular filtration rate;glycosylated hemoglobin;Urine metabolomics;

Secondary Outcome Measures

Name	Time	Method
TCM syndrome score;blood fat;uric acid;