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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 730
- Locations
- 1
- Primary Endpoint
- Proportion of type 2 diabetes mellitus (T2DM) patients with cardiovascular risk factors (CVRFs) and/or established cardiovascular disease (CVD), regardless the date of diagnosis
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Proportion of type 2 diabetes mellitus (T2DM) patients with cardiovascular risk factors (CVRFs) and/or established cardiovascular disease (CVD), regardless the date of diagnosis
Time Frame: Baseline (month 0)
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
Secondary Outcomes
- Change in body mass index(During 3 years before baseline (0 to -36 months))
- Hospital appointments(During 3 years before baseline (0 to -36 months))
- Change in total cholesterol(During 3 years before baseline (0 to -36 months))
- Hyperglycaemic episodes(During 3 years before baseline (0 to -36 months))
- Change in urine albumin(During 3 years before baseline (0 to -36 months))
- Change in Estimated Glomerular Filtration Rate (eGFR)(During 3 years before baseline (0 to -36 months))
- Change in high-density lipoprotein cholesterol(During 3 years before baseline (0 to -36 months))
- Type of pharmacological treatment(During 3 years before baseline (0 to -36 months))
- Hypoglycaemic episodes(During 3 years before baseline (0 to -36 months))
- Change in blood pressure(During 3 years before baseline (0 to -36 months))
- Change in glycosylated hemoglobin (HbA1c)(During 3 years before baseline (0 to -36 months))
- Change in low-density lipoprotein cholesterol(During 3 years before baseline (0 to -36 months))
- Presence of T2DM complications (yes/no)(During 3 years before baseline (0 to -36 months))
- Types of T2DM complications(During 3 years before baseline (0 to -36 months))
- Hospitalisation episodes(During 3 years before baseline (0 to -36 months))
- Emergency visits(During 3 years before baseline (0 to -36 months))
- Change in waist circumference(During 3 years before baseline (0 to -36 months))
- Change in HbA1c(During 3 years before baseline (0 to -36 months))
- Change in triglyceride(During 3 years before baseline (0 to -36 months))