A Study of People With Type 2 Diabetes Who Have Diseases That Affect the Heart and Blood Vessels. The Study Will Also Look at the Treatment of a Group of These People in Hospitals in Portugal

Study Overview
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Brief Summary
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This study aims to estimate the number of patients with cardiovascular disease and risk factors in patients who had been diagnosed with type 2 diabetes mellitus. Simultaneously, this study also intends to obtain more information about the management of type 2 diabetes mellitus patients with established cardiovascular disease. This study is non-interventional, which means that will not require participant's further related visits or procedures. The study will collect the participant's clinical data from the current visit and, when applicable, within the last 3 years.

Official Title
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An Observational Cross-sectional Study to Estimate the Prevalence of Cardiovascular Disease and CV Risk Factors in T2DM Patients Including a Retrospective Phase to Evaluate the Clinical Management of a Subgroup of Patients in the Hospital Setting in Portugal

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: No treatment given


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Main study population (Data collection - Prevalence): Signed Informed Consent Form (ICF) obtained before any study-related activities (study-related activities are any procedures related to recording of data according to protocol) Male or female patient, age greater or equal to 18 years at the time of signing ICF Patients diagnosed with type 2 diabetes Subgroup (Data collection - Patient management): Patients followed at the hospital setting by the endocrinologist or internal medicine specialist (ambulatory diabetes management) and with available medical records, retrospectively within the last three years Patients with type 2 diabetes mellitus and established cardiovascular disease diagnosed at least three years ago Exclusion Criteria: Previous participation in this study. Participation is defined as signed ICF Female patient who is pregnant or breast-feeding Patients with type 1 diabetes Participation in a clinical trial within the last 3 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with type 2 diabetes mellitus (T2DM)<br>Patients with type 2 diabetes, at the hospital setting. | Other: No treatment given<br>* No treatment is administered to the participants for this study<br>|
| Patients with T2DM and established cardiovascular disease<br>Subgroup of patients with type 2 diabetes and established cardiovascular disease | Other: No treatment given<br>* No treatment is administered to the participants for this study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of type 2 diabetes mellitus (T2DM) patients with cardiovascular risk factors (CVRFs) and/or established cardiovascular disease (CVD), regardless the date of diagnosis | Proportion of subjects. CVRFs are defined as a history of one or more of the following criteria: Overweight or obese Family history of CVD (1st degree) Hypertension Hypercholesterolemia Low high-density lipoproteins Hypertriglyceridemia Smoking habits Sedentary lifestyle -as per Investigator discretion according to his/her normal practice. CVD is defined as a history of one or more of the following events: Stroke Transient ischaemic attack Ischaemic heart disease including myocardial infarction Congestive heart failure Atrial fibrillation Aortic aneurism Peripheral or carotid artery disease | Baseline (month 0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoglycaemic episodes | Number of episodes | During 3 years before baseline (0 to -36 months) | 
| Hyperglycaemic episodes | Number of episodes | During 3 years before baseline (0 to -36 months) | 
| Presence of T2DM complications (yes/no) | Number of patients for whom 'presence of T2DM complications' has been answered yes/no respectively | During 3 years before baseline (0 to -36 months) | 
| Types of T2DM complications | Types of T2DM complications: Retinopathy, Diabetic neuropathy (peripheral, autonomic), Diabetic nephropathy, Amputation. | During 3 years before baseline (0 to -36 months) | 
| Hospital appointments | Number of cardiology, ophthalmology, nephrology, and vascular surgery appointments | During 3 years before baseline (0 to -36 months) | 
| Hospitalisation episodes | Number of episodes | During 3 years before baseline (0 to -36 months) | 
| Emergency visits | Number of visits | During 3 years before baseline (0 to -36 months) | 
| Change in waist circumference | Measured in cm | During 3 years before baseline (0 to -36 months) | 
| Change in body mass index | Measured in kg/m^2 | During 3 years before baseline (0 to -36 months) | 
| Change in blood pressure | Measured in mmHg | During 3 years before baseline (0 to -36 months) | 
| Change in urine albumin | Measured in mg/24 hours | During 3 years before baseline (0 to -36 months) | 
| Change in urine albumin | Measured in microgram/minute | During 3 years before baseline (0 to -36 months) | 
| Change in glycosylated hemoglobin (HbA1c) | Measured in mmol/mol | During 3 years before baseline (0 to -36 months) | 
| Change in HbA1c | Measured in % | During 3 years before baseline (0 to -36 months) | 
| Change in Estimated Glomerular Filtration Rate (eGFR) | Measured in mL/min/1.73 m^2 | During 3 years before baseline (0 to -36 months) | 
| Change in total cholesterol | measured in mg/dl | During 3 years before baseline (0 to -36 months) | 
| Change in low-density lipoprotein cholesterol | measured in mg/dl | During 3 years before baseline (0 to -36 months) | 
| Change in high-density lipoprotein cholesterol | measured in mg/dl | During 3 years before baseline (0 to -36 months) | 
| Change in triglyceride | measured in mg/dl | During 3 years before baseline (0 to -36 months) | 
| Type of pharmacological treatment | Types of pharmacological treatment: Antidiabetics Antihypertensive Lipid lowering therapy Antiplatelet/anticoagulant therapy | During 3 years before baseline (0 to -36 months) |