Type 2 diabetes mellitus
Conditions
Interventions
Luohe City type 2 diabetes population panvascular disease cohort:None
Sponsors
Luohe Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years; 2. Hospitalized, received outpatient care, followed up, or managed at Luohe Central Hospital or within the network hospitals of the Luohe Central Hospital Medical Group, with access to major clinical data and key diagnostic and treatment information; 3. Meets the diagnostic criteria for type 2 diabetes: previously clearly diagnosed by a medical institution with medical records or glucose-lowering treatment records; or baseline review meets the diagnostic criteria for diabetes [fasting plasma glucose >= 7.0 mmol/L, 2-hour plasma glucose >= 11.1 mmol/L during a 75 g oral glucose tolerance test, HbA1c >= 6.5%, or typical symptoms of hyperglycemia/hyperglycemic crisis with random plasma glucose >= 11.1 mmol/L]. For those without typical symptoms, another abnormal indicator from the same sample or repeated testing on different dates should be used for confirmation; and type 1 diabetes, gestational diabetes, and other specific types of diabetes should be excluded based on clinical phenotype, islet function, and autoantibodies. 4. Core glucose metabolism data (including at least HbA1c or fasting blood glucose) and basic medical history and contact information required for determining primary endpoints are available within the baseline window. Fundus, peripheral nerve, kidney, and pan-vascular assessments should be completed as much as possible according to the protocol; those who have not completed fundus or peripheral nerve assessments can still enter the MACCE main analysis cohort but will not enter the corresponding microvascular secondary outcome analysis set. 5. The subject themselves or their legal guardian/fixed caregiver is willing and able to accept a 30-year follow-up (once every year after baseline, primarily through outpatient/offline centralized visits, with telephone and medical record supplementary follow-ups when necessary), and can provide valid contact information (the subject themselves and at least one relative/contact person).
Exclusion criteria
Exclusion criteria: 1.Patients with critically unstable acute conditions who are deemed unable to complete baseline assessment or follow-up by the research team; 2.Patients in the acute unstable phase of acute myocardial infarction/acute coronary syndrome, acute stroke or acute decompensated heart failure; 3.Patients complicated with active malignant tumors, end-stage organ failure or other severe non-cardiovascular diseases, with markedly limited life expectancy (e.g., less than 1 year) or conditions that severely hinder follow-up; 4.Patients with severe mental disorders, disturbance of consciousness or cognitive impairment who cannot cooperate with questionnaires and follow-up, and have no eligible legal representative or primary caregiver for assistance; 5.Patients without valid contact information or confirmed inability to receive long-term follow-up; 6.Pregnant women (including confirmed pregnancy and patients with high clinical suspicion of pregnancy); 7.Patients with severe missing key data for diabetes diagnosis, glycemic metabolism or outcome adjudication, which prevents baseline risk assessment and long-term outcome evaluation. Those who fail to complete fundoscopy, sensory threshold measurement, brachial-ankle pulse wave velocity or ankle-brachial index due to technical reasons but have complete other core data can be enrolled, with pre-specified missing data handling and sensitivity analysis adopted in statistical analysis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| First occurrence of MACCE; | — |
Secondary
| Measure | Time frame |
|---|---|
| New-onset diabetic retinopathy;Progression of existing retinopathy;Vision-threatening diabetic retinopathy;Diabetic macular edema and related ophthalmologic treatments;New-onset diabetic peripheral neuropathy;Number of abnormal findings on screening and changes in vibration perception threshold;Loss of protective sensation and painful diabetic neuropathy;Diabetic foot ulcer;Non-traumatic amputation;New-onset or progressive diabetic kidney disease;End-stage renal disease;Peripheral arterial, carotid, renal, and aortic-related events;Other hospitalizations;Control of risk factors;Changes in vascular function/imaging parameters;Continued medication use;Lifestyle;Psychological and sleep status;Cognitive function;Changes in Traditional Chinese Medicine constitution score; | — |
Countries
China
Contacts
Public ContactWang Haoran
Luohe Central Hospital
Outcome results
None listed