Chongqing Diabetes Registry Study

Recruiting

• Conditions: Diabetes Mellitus

• Registration Number: NCT03692884
• Lead Sponsor: Chongqing Medical University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2018-07-01
• Study First Submitted: 2018-07-17
• Study First Submitted QC: 2018-09-30
• Study First Posted: 2018-10-02
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-04
• Last Update Posted: 2023-09-06
• Primary Completion: 2030-07-01
• Study Completion: 2030-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

1. Diagnosis of diabetes mellitus（based on the 1999 WHO diagnostic cretirial）;
2. Age younger than 75 years old, gender is not limited;
3. Voluntary to sign on the informed consent.

Exclusion Criteria

1. pregnant or breast-feeding women;
2. Patients with chronic disease requiring long-term glucocorticoid therapy;
3. Patients with severe infection (except for diabetic foot) or immune dysfunction.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The number of patients whoes Diabetic Kidney disease (DKD) is worsen	5 years	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.

Secondary Outcome Measures

Name	Time	Method
The number of patients who develop Diabetic Retinopathy	5 years	New Diabetic Retinopathy
The number of patients who develop Cardiovascular events	10 years	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.
The number of patients who develop DKD	5 years	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.
The number of patients whoes DR is worsen	5 years	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.
The number of patients who develop Diabetic foot	10 years	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.
The number of patients who develop Diabetic Neuropathy	5 years	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).

Trial Locations

Locations (1)

Qifu Li; 🇨🇳 Chongqing, Chongqing, China