Trial Outcomes & Findings for Tianjin Diabetes and Health Cohort Study (NCT NCT06913153)

Last Updated: 2025-05-25

Results Overview

Diabetic Complications: diabetic retinopathy,diabetic nephropathy,cerebral infarction,coronary artery disease The diagnosis of coronary artery disease is based on a comprehensive assessment of the degree of coronary artery stenosis and evidence of myocardial ischemia, taking into account risk factors and clinical symptoms, and exclusion of other similar diseases. The diagnostic criteria for diabetic nephropathy are history of diabetes: clear and long history of diabetes, Urine protein test:Urinary microalbumin excretion rate (UACR) is a key indicator for early diagnosis, with a normal value of less than 30mg/g, 30-300m Diagnosis of diabetic retinopathy by fundus examination. Diagnostic criteria for cerebral infarction are ICD codes or the doctor's diagnosis. Data collection through chart review, patient self-reporting, imaging

Recruitment status

COMPLETED

Target enrollment

396983 participants

Primary outcome timeframe

Baseline and week 520

Results posted on

2025-05-25

Participant Flow

This study is a real-world observational study and does not involve individual interventions or corresponding group assignment.

Participant milestones

Participant milestones
Measure	Cohort Comparising Patients With Diabetes This dynamic cohort comparised 396983 diabetic patients who were enrolled in second- and tertiary-level hospitals in Tianjin during 2009-2024. All the participants had at least three medical visits.
Overall Study STARTED	396983
Overall Study COMPLETED	396983
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tianjin Diabetes and Health Cohort Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort Comparising Patients With Diabetes n=396983 Participants This dynamic cohort comparised 396983 diabetic patients who were enrolled in second- and tertiary-level hospitals in Tianjin during 2009-2024. All the participants had at least three medical visits.
Age, Continuous	58 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	181412 Participants n=5 Participants
Sex: Female, Male Male	215571 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	396983 Participants n=5 Participants
Race/Ethnicity, Customized Race · Non-Asian	0 Participants n=5 Participants
Region of Enrollment China	396983 Participants n=5 Participants
medical history The number of people with hypertension	230484 Participants n=5 Participants
medical history The number of people without hypertension	166499 Participants n=5 Participants
fasting glucose	10.19 mmol/L STANDARD_DEVIATION 4.01 • n=5 Participants
glycated hemoglobin	7.43 % STANDARD_DEVIATION 3.22 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and week 520

Population: All the participants in the cohort are included in the analysis.

Outcome measures

Outcome measures
Measure	Coronary Artery Disease n=396983 Participants The diagnosis of coronary artery disease is based on a comprehensive assessment of the degree of coronary artery stenosis and evidence of myocardial ischemia, taking into account risk factors and clinical symptoms, and exclusion of other similar diseases.The results for each outcome measure are presented in a table in which the columns represent the study's arms or comparison (analysis) groups and the rows present summary-level data. Each statistical analysis is similarly reported in a table that immediately follows the relevant outcome measure.	Cerebral Infarction n=396983 Participants Acute Onset and Symptomatic Features Sudden symptom onset, reaching peak within minutes to several hours, characterized by focal neurological deficits (e.g., unilateral limb weakness/numbness, speech disorders, facial asymmetry, visual disturbances, etc.). Symptom duration exceeds 24 hours, or imaging reveals a responsible ischemic lesion (e.g., CT hypodensity, MRI diffusion restriction). Imaging Evidence Head CT Scan: Excludes intracranial hemorrhage during the acute phase; low-density infarct lesions appear 24-48 hours post-onset. MRI (DWI Sequence): Highly sensitive, detecting ischemic lesions within minutes of symptom onset; preferred for early diagnosis. Vascular Imaging (CTA/MRA): Evaluates stenosis or occlusion of carotid/intracranial arteries, clarifying vascular lesion location and severity. Etiological Classification (at least one criterion must be met) Large Artery Atherosclerosis Type: Vascular stenosis \>50% or occlusion with pathological atherosclerosis changes, excluding cardioembolic sources. Cardioembolic Type: Emboli of cardiac origin (e.g., atrial fibrillation, post-myocardial infarction mural thrombi) causing cerebral arterial occlusion, supported by ECG/echocardiographic evidence. Small Artery Occlusion Type (Lacunar Infarction): Infarct diameter \<1.5-2.0 cm, predominantly in hypertensive patients, with mild symptoms and favorable prognosis.	Diabetic Retinopathy n=396983 Participants Diagnosis of diabetic retinopathy by fundus examination.	Diabetic Nephropathy n=396983 Participants The diagnostic criteria for diabetic nephropathy are history of diabetes: clear and long history of diabetes, Urine protein test:Urinary microalbumin excretion rate (UACR) is a key indicator for early diagnosis, with a normal value of less than 30mg/g, 30-300m
Diabetes Complications Patients presenting with any of the aforementioned clinical outcomes	10263 Participants	97864 Participants	59029 Participants	69822 Participants
Diabetes Complications Patients presenting without any of the aforementioned clinical outcomes	386720 Participants	299119 Participants	337954 Participants	327161 Participants

SECONDARY outcome

Timeframe: baseline and week 520

Average level of glucose: including Glycated Hemoglobin (HbA1c), the mean of fasting glucose(FG) Glucose Variability: including standard deviation, coefficient of variation of HbA1c and FG.

Outcome measures

Outcome measures
Measure	Coronary Artery Disease n=396983 Participants The diagnosis of coronary artery disease is based on a comprehensive assessment of the degree of coronary artery stenosis and evidence of myocardial ischemia, taking into account risk factors and clinical symptoms, and exclusion of other similar diseases.The results for each outcome measure are presented in a table in which the columns represent the study's arms or comparison (analysis) groups and the rows present summary-level data. Each statistical analysis is similarly reported in a table that immediately follows the relevant outcome measure.	Cerebral Infarction Acute Onset and Symptomatic Features Sudden symptom onset, reaching peak within minutes to several hours, characterized by focal neurological deficits (e.g., unilateral limb weakness/numbness, speech disorders, facial asymmetry, visual disturbances, etc.). Symptom duration exceeds 24 hours, or imaging reveals a responsible ischemic lesion (e.g., CT hypodensity, MRI diffusion restriction). Imaging Evidence Head CT Scan: Excludes intracranial hemorrhage during the acute phase; low-density infarct lesions appear 24-48 hours post-onset. MRI (DWI Sequence): Highly sensitive, detecting ischemic lesions within minutes of symptom onset; preferred for early diagnosis. Vascular Imaging (CTA/MRA): Evaluates stenosis or occlusion of carotid/intracranial arteries, clarifying vascular lesion location and severity. Etiological Classification (at least one criterion must be met) Large Artery Atherosclerosis Type: Vascular stenosis \>50% or occlusion with pathological atherosclerosis changes, excluding cardioembolic sources. Cardioembolic Type: Emboli of cardiac origin (e.g., atrial fibrillation, post-myocardial infarction mural thrombi) causing cerebral arterial occlusion, supported by ECG/echocardiographic evidence. Small Artery Occlusion Type (Lacunar Infarction): Infarct diameter \<1.5-2.0 cm, predominantly in hypertensive patients, with mild symptoms and favorable prognosis.	Diabetic Retinopathy Diagnosis of diabetic retinopathy by fundus examination.	Diabetic Nephropathy The diagnostic criteria for diabetic nephropathy are history of diabetes: clear and long history of diabetes, Urine protein test:Urinary microalbumin excretion rate (UACR) is a key indicator for early diagnosis, with a normal value of less than 30mg/g, 30-300m
Glycemic Control	8.7 mmol/L Standard Deviation 3.36	—	—	—

SECONDARY outcome

Timeframe: baseline and week 520

death from all cause, diabetes complications, and cancer.

Outcome measures

Outcome measures
Measure	Coronary Artery Disease n=396983 Participants The diagnosis of coronary artery disease is based on a comprehensive assessment of the degree of coronary artery stenosis and evidence of myocardial ischemia, taking into account risk factors and clinical symptoms, and exclusion of other similar diseases.The results for each outcome measure are presented in a table in which the columns represent the study's arms or comparison (analysis) groups and the rows present summary-level data. Each statistical analysis is similarly reported in a table that immediately follows the relevant outcome measure.	Cerebral Infarction Acute Onset and Symptomatic Features Sudden symptom onset, reaching peak within minutes to several hours, characterized by focal neurological deficits (e.g., unilateral limb weakness/numbness, speech disorders, facial asymmetry, visual disturbances, etc.). Symptom duration exceeds 24 hours, or imaging reveals a responsible ischemic lesion (e.g., CT hypodensity, MRI diffusion restriction). Imaging Evidence Head CT Scan: Excludes intracranial hemorrhage during the acute phase; low-density infarct lesions appear 24-48 hours post-onset. MRI (DWI Sequence): Highly sensitive, detecting ischemic lesions within minutes of symptom onset; preferred for early diagnosis. Vascular Imaging (CTA/MRA): Evaluates stenosis or occlusion of carotid/intracranial arteries, clarifying vascular lesion location and severity. Etiological Classification (at least one criterion must be met) Large Artery Atherosclerosis Type: Vascular stenosis \>50% or occlusion with pathological atherosclerosis changes, excluding cardioembolic sources. Cardioembolic Type: Emboli of cardiac origin (e.g., atrial fibrillation, post-myocardial infarction mural thrombi) causing cerebral arterial occlusion, supported by ECG/echocardiographic evidence. Small Artery Occlusion Type (Lacunar Infarction): Infarct diameter \<1.5-2.0 cm, predominantly in hypertensive patients, with mild symptoms and favorable prognosis.	Diabetic Retinopathy Diagnosis of diabetic retinopathy by fundus examination.	Diabetic Nephropathy The diagnostic criteria for diabetic nephropathy are history of diabetes: clear and long history of diabetes, Urine protein test:Urinary microalbumin excretion rate (UACR) is a key indicator for early diagnosis, with a normal value of less than 30mg/g, 30-300m
Death Number of all-cause deaths	21669 Participants	—	—	—
Death Number of deaths not due to all causes	375314 Participants	—	—	—

Adverse Events

Cohort Comparising Patients With Diabetes

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Zhenqiang Song, M.S., Associate Professor and Master's Supervisor

Tianjin Medical University

Phone: 8622-18602276218

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place