Chongqing Diabetes Registry Study

Diabetes Mellitus Clinical Trial

— CDR  

Official title:

Chongqing Diabetes and Its Chronic Complications Registry Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03692884
• Other study ID #: CDR2018
• Status: Recruiting
• Start date: July 1, 2018
• Est. completion date: July 1, 2030

Study information

• Verified date: September 2023
• Source: Chongqing Medical University
• Contact: Qifu Li, phD
• Phone: +86 023-89011552
• Email: liqifu[@]yeah.net
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: July 1, 2030
• Est. primary completion date: July 1, 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus

Locations

Country	Name	City	State
China	Qifu Li	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	The number of patients who develop Diabetic Retinopathy	New Diabetic Retinopathy	5 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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