Diabetes MellitusCDRNCT03692884
Chongqing Diabetes Registry Study
An observational study of Diabetes Mellitus, run by Chongqing Medical University at 1 site in China.
Trial summary
To investigate the risk factors and biomarkers of the microvascular disease，macrovascular disease and neuropathy in patients with diabetes. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2018to 1 Jul 2030
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Qifu Li
Chongqing, Chongqing Municipality, 400016
Qifu Li, PhD, +86 23 89011552, liqifu@yeah.net
Zhihong Wang, phD
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Mellitus
- Keywords
- diabetes mellitus, risk factors, biomarkers, chronic diabetes complications
- Medical subject headings
- Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (6)
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.
Measured: 5 years
The number of patients who develop Diabetic Retinopathy
New Diabetic Retinopathy
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start1 Jul 2018
- Primary completion1 Jul 2030 (estimated)
- Study completion1 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qifu Li, Chongqing Medical University
- Investigators
- Qifu Li, phD, Study chair, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03692884
- Sponsor's protocol ID
- CDR2018
- Acronym
- CDR
- Status last verified
- Sep 2023
- First submitted
- 17 Jul 2018
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 34305401
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chongqing Diabetes and Its Chronic Complications Registry Study
- ClinicalTrials.gov ID
- NCT03692884
- Acronym / sponsor ID
- CDR / CDR2018
- Conditions
- Diabetes Mellitus
- Keywords
- diabetes mellitus, risk factors, biomarkers, chronic diabetes complications
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Jul 2030 (estimated)
- Study completion
- 1 Jul 2030 (estimated)
- First posted
- 2 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
The number of patients who develop DKD
Time frame: 5 years
The number of patients who develop Diabetic Retinopathy
Time frame: 5 years
The number of patients whoes DR is worsen
Time frame: 5 years
The number of patients who develop Diabetic Neuropathy
Time frame: 5 years
The number of patients who develop Cardiovascular events
Time frame: 10 years
The number of patients who develop Diabetic foot
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Derived from this study: PubMed 34305401Lv 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Qifu Li, phD study chair
First Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qifu Li, phD (+86 023-89011552, liqifu@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients whoes Diabetic Kidney disease (DKD) is worsen (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03692884, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.