Chongqing Diabetes Registry

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Qifu Li，First Affiliated Hospital of Chongqing Medical University

Tracking Information

First Submitted Date ^ICMJE

July 17, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 2, 2018

Actual Study Start Date ^ICMJE

July 1, 2018

Estimated Primary Completion Date

July 1, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The number of patients who develop Diabetic Kidney disease (DKD)[ Time Frame: 5 years ]

Diabetic Kidney Disease is defined as Urine Albumin Creatinine Ratio （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 DKD is worsen[ Time Frame: 5 years ]

Worsen DKD is defined as 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.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

The number of patients who develop Diabetic Retinopathy[ Time Frame: 5 years ]
New Diabetic Retinopathy
The number of patients whoes DR is worsen[ Time Frame: 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 Neuropathy[ Time Frame: 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).
The number of patients who develop Cardiovascular events[ Time Frame: 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 Diabetic foots[ Time Frame: 10 years ]

Descriptive Information

Brief Title ^ICMJE

Chongqing Diabetes Registry

Official Title ^ICMJE

Chongqing Diabetes Registry

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 Type ^ICMJE

Observational [Patient Registry]

Study Phase

Study Design ^ICMJE

Allocation:
Intervention Model:
Intervention Model Description:
Masking: Observational [Patient Registry]
Masking Description:
Primary Purpose:

Condition ^ICMJE

Intervention ^ICMJE

Study Arms

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

5000

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

July 1, 2030

Estimated Primary Completion Date

July 1, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

China

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Qifu Li，First Affiliated Hospital of Chongqing Medical University

Study Sponsor ^ICMJE

Chongqing Medical University

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair: Qifu Li, phD First Affiliated Hospital of Chongqing Medical University

PRS Account

First Affiliated Hospital of Chongqing Medical University

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

请使用微信扫码报名