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NCT Number: NCT03692884

Chongqing Diabetes Registry Study

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

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Qifu Li

Chongqing, Chongqing Municipality, 400016, China

Location status: Recruiting

Location contact

Jinbo Hu, phD

SUB_INVESTIGATOR

Lilin Gong, phD

SUB_INVESTIGATOR

Qifu Li, PhD

CONTACT

[email protected]

+86 23 89011552

Qingfeng Cheng, phD

SUB_INVESTIGATOR

Shumin Yang, phD

SUB_INVESTIGATOR

Yue Wang, phD

SUB_INVESTIGATOR

Zhihong Wang, phD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. The number of patients whoes Diabetic Kidney disease (DKD) is worsen

    Time frame: 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 outcomes

  1. The number of patients who develop DKD

    Time frame: 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.

  2. The number of patients who develop Diabetic Retinopathy

    Time frame: 5 years

    New Diabetic Retinopathy

  3. 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.

  4. 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).

  5. 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.

  6. The number of patients who develop Diabetic foot

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Qifu Li, phD

CONTACT

[email protected]

+86 023-89011552

Zhihong Wang, phD

CONTACT

[email protected]

+86 023-89011552

Sponsors and collaborators

Lead sponsor

Chongqing Medical University

Other

Registry information

Official study title

Chongqing Diabetes and Its Chronic Complications Registry Study

Acronym: CDR

Important dates

Study start
2018
Primary completion
2030
Study completion
2030
First posted
Oct 2, 2018
Registry last updated
Sep 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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