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A quantitative diagnosis model building of common TCM Syndromes of kidney disease.

A quantitative diagnosis model building of common TCM Syndromes of kidney disease.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OCH-14004799
Enrollment
Unknown
Registered
2014-06-05
Start date
2014-06-30
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes mellitus and Diabetic nephropathy

Interventions

4 groups:survey on TCM Syndromes

Sponsors

Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. People at risk of diabetes (metabolic syndrome): Refer toThe diagnostic criteria for the metabolic syndrome in the China guideline for type 2 diabetes published by The Chinese Medical Association Diabetes branchexcluding diabetes; Aged 18-75years old, have the following 4 components in 3 or all of them: (1) The overweight and/or obesity: BMl = 25 kg / m2; (2) The high blood sugar: impaired fasting glucose (IFG) or impaired glucose tolerance (IGT). FBG 6.1~6.9 mmol/L, 2hPG 7.8~11.1mmol/L in OGTT test; (3) Hypertension:BP>140/90mmHg and/or having been diagnosed and treated; (4) Dyslipidemia:the fasting plasma triglyceride (TG) = 1.7 mmol/L, and/or fasting HDL-C 30 mg/g (3.4mg/mmol)); (4) no diabetic peripheral neuropathy, no diabetic retinopathy; 3. Diabetic nephropathy microalbuminuria period: (1) Aged 18-75 years old, signed the informed consent; (2) Didbetes having been diagnosed,urinary microalbuminuria positive twice (cchosing urinary albumin / creatinine ratio (ACR) 30-300mg/g (3.4-33.9mg/mmol)at anytime) or 24h microalbuminuria quantitative 20-200 mg/L; or urinary albumin excretion rate (UAER) 20-200 g/min (30-300mg/24h); negative urine protein in urine routine, 24h urinary protein 0.5g; or 24h microalbuminuria quantitative > 200 mg/L; or urinary albumin / creatinine ratio (ACR)>300mg/g (33.9mg/mmol); or urinary albumin excretion rate (UAER) > 200 ug/min (300mg/24h); GFR decreased but not less than 15ml/min; (3) Excluding non diabetic nephropathy; (4) A renal biopsy to exclude other nephropathy; Biopsy: a history of diabetes for less than 10 years, persistent proteinuria but no retinopathy; acute deterioration of renal function; microscopic hematuria or with red blood cell casts.

Exclusion criteria

Exclusion criteria: 1. People at risk of diabetes (metabolic syndrome) exclusion criteria: (1) Diagnosed as diabetes; (2) Malignant hypertension, myocardial infarction, cerebral vascular accident and other critical diseases history in the last 6 month; (3) Complicated with severe respiratory, digestive, blood, urinary system, primary diseases and the concurrent infection and insane; (4) Complicated with congestive heart failure at grade I-IV; (5) Having cancer or pregnancy or in the lactation; 2. Diabetes exclusion criteria: (1) Complicated with diabetic nephropathy; (2) Except for other renal diseases, including primary glomerular disease, autoimmune disease and connective tissue diseases, blood diseases, cancer, drug secondary renal damage; (3) Malignant hypertension, myocardial infarction, cerebral vascular accident and diabetic ketoacidosis and other critical diseases history in the last 6 months; (4) Complicated with severe respiratory, digestive, blood system disease and the concurrent infection and insane; (5) Complicated with congestive heart failure in grade I-IV; (6) Having cancer or pregnancy or in the lactation; 3. Diabetic nephropathy microalbuminuria period exclusion criteria: (1) Except for other renal diseases,including primary glomerular disease, autoimmune disease and connective tissue diseases, blood diseases, cancer, drug secondary renal damage; (2) Malignant hypertension, myocardial infarction, cerebral vascular accident and diabetic ketoacidosis and other critical diseases history in the last 6 months; (3) Complicated with severe respiratory, digestive, blood system disease and the concurrent infection and insane; (4) Complicated with congestive heart failure at grade I-IV; (5) Having cancer or pregnancy or in the lactation; 4. Diabetic nephropathy protein urine period exclusion criteria: Similar to the third one.

Design outcomes

Primary

MeasureTime frame
blood routine test;Urine routine test;Fasting blood glucose;24h quantitative urinary protein;Glycated hemoglobin;Urinary albumin / creatinine ratio;Total protein;Albumin;blood urine nitrogen;serum creatinine;uric acid;kalium;Calcium;Phosphorus;Total cholesterol;Triglyceride;Low density lipoprotein;High density lipoprotein;Fundus examination after mydriasi;

Countries

China

Contacts

Public ContactHongfang Liu

Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine

lhfdoctor@sohu.com+86 010-84013205

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026