Chongqing Diabetes Registry Study

Study Overview
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Brief Summary
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To investigate the risk factors and biomarkers of the microvascular disease，macrovascular disease and neuropathy in patients with diabetes.

Detailed Description
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This study is a prospective cohort study. About 5000 patients with diabetes from the Chongqing Diabetes Centre,Chongqing,China, will be enrolled for long-term follow-up.Information on socio-demographic parameters, medical history, current drug use,lifestyle factors, anthropometric measurements, metabolic control indicators and diabetes complications examination will be documented. Blood and urine samples will be collected. This study aimed to assess risk factors and biomarkers of occurrence and development of diabetic microvascular disease,macrovascular disease and neuropathy in patients with diabetes.

Official Title
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Chongqing Diabetes and Its Chronic Complications Registry Study

Conditions
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Diabetes Mellitus

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of diabetes mellitus（based on the 1999 WHO diagnostic cretirial）; Age younger than 75 years old, gender is not limited; Voluntary to sign on the informed consent. Exclusion Criteria: pregnant or breast-feeding women; Patients with chronic disease requiring long-term glucocorticoid therapy; Patients with severe infection (except for diabetic foot) or immune dysfunction.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients whoes Diabetic Kidney disease (DKD) is worsen | Worsen DKD is defined as Urine Albumin Creatinine Ratio （UACR）> 300 mg/g Cr（twice out of three measures）, or 24 hours urinary protein> 300 mg / 24 h, or double serum creatinine level and at least 200μmol/l (2.26 mg/dl), or require renal replacement therapy, or death due to kidney disease. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients who develop DKD | Diabetic Kidney Disease is defined as UACR > 30 mg/g Cr（twice out of three measures），or estimated Glomerular Filtration Rate（eGFR）<60ml/min/1.73m2. | 5 years | 
| The number of patients who develop Diabetic Retinopathy | New Diabetic Retinopathy | 5 years | 
| The number of patients whoes DR is worsen | Worsen DKD is defined as any eye with original Diabetic Rretinopathy aggravated by at least one level, or progress to proliferation retinopathy, or appearance of macular degeneration, or at least one eye with blindness (refer to the WHO standards, the Snellen-chart vision drop to 6/60 or less), or to accept retinal photocoagulation treatment, or accept vitrectomy. | 5 years | 
| The number of patients who develop Diabetic Neuropathy | Diabetic Peripheral Neuropathy is defined as Neuropathy Symptom Score/Neuropathy Disability Score（NSS/NDS） with at least two positive outcomes, or electromyography examination to identify nerve damage；Diabetic Autonomic Neuropathy is defined as tachycardia at rest (Heart Ratio>100bpm) and postural hypotension (standing position leads systolic blood pressure reduction >20mmHg). | 5 years | 
| The number of patients who develop Cardiovascular events | Cardiovascular events are difined as death of cardiovascular events, or non-fatal myocardial infarction, or non-fatal stroke, or revascularization procedure (cardiac, carotid, or peripheral), or hospitalization for heart failure. | 10 years | 
| The number of patients who develop Diabetic foot | Diabetic foot was defined as active diabetic foot problem: ulceration, spreading infection, critical ischaemia, gangrene, suspicion of an acute Charcot arthropathy, or an unexplained hot, red, swollen foot with or without pain. | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus, risk factors, biomarkers, chronic diabetes complications