Clinical trial NCT03692884: Chongqing Diabetes Registry Study
Official title: Chongqing Diabetes and Its Chronic Complications Registry Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus
Keywords: diabetes mellitus
risk factors
biomarkers
chronic diabetes complications
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2018-10-02
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The number of patients whoes Diabetic Kidney disease (DKD) is worsen
timeFrame: 5 years
Secondary outcomes:
measure: The number of patients who develop DKD
timeFrame: 5 years
measure: The number of patients who develop Diabetic Retinopathy
timeFrame: 5 years
measure: The number of patients whoes DR is worsen
timeFrame: 5 years
measure: The number of patients who develop Diabetic Neuropathy
timeFrame: 5 years
measure: The number of patients who develop Cardiovascular events
timeFrame: 10 years
measure: The number of patients who develop Diabetic foot
timeFrame: 10 years
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Qifu Li
state: Chongqing
Study officials:
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Qifu Li, phD
role: STUDY_CHAIR
References:
citation: 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.