Chongqing Diabetes Registry Study (CDR)

Chongqing Diabetes and Its Chronic Complications Registry Study

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

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus

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: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Zhihong Wang, phD; Phone Number: +86 023-89011552; Email: towzh713@126.com
• Study Contact Backup: Name: Qifu Li, PhD; Phone Number: +86 023-89011552; Email: liqifu@yeah.net

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400016
      • Recruiting
      • Qifu Li
      • Sub-Investigator: Shumin Yang, phD
      • Sub-Investigator: Qingfeng Cheng, phD
      • Sub-Investigator: Zhihong Wang, phD
      • Sub-Investigator: Jinbo Hu, phD
      • Sub-Investigator: Yue Wang, phD
      • Sub-Investigator: Lilin Gong, phD
      • Contact: Qifu Li, PhD; Phone Number: +86 23 89011552; Email: liqifu@yeah.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

The subjects who diagnosed of diabetes mellitus and signed on the informed consent will be enrolled in our study. We intend to enroll hospitalized patients or outpatient with diabetes mellitus from Chongqing Diabetes Centre,Chongqing,China.

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Lv L, Zhou Y, Chen X, Gong L, Wu J, Luo W, Shen Y, Han S, Hu J, Wang Y, Li Q, Wang Z; Chongqing Diabetes Registry Group. Relationship Between the TyG Index and Diabetic Kidney Disease in Patients with Type-2 Diabetes Mellitus. Diabetes Metab Syndr Obes. 2021 Jul 17;14:3299-3306. doi: 10.2147/DMSO.S318255. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030

Study Registration Dates

• First Submitted: July 17, 2018
• First Submitted That Met QC Criteria: September 30, 2018
• First Posted (Actual): October 2, 2018

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 4, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: biomarkers; risk factors; diabetes mellitus; chronic diabetes complications
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: CDR2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No