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Completed

NCT Number: NCT03797885

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site, Almada, Portugal

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No treatment given

Other

No treatment is administered to the participants for this study

Primary outcomes

  1. 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

  1. Hypoglycaemic episodes

    Time frame: During 3 years before baseline (0 to -36 months)

    Number of episodes

  2. Hyperglycaemic episodes

    Time frame: During 3 years before baseline (0 to -36 months)

    Number of episodes

  3. Presence of T2DM complications (yes/no)

    Time frame: During 3 years before baseline (0 to -36 months)

    Number of patients for whom 'presence of T2DM complications' has been answered yes/no respectively

  4. Types of T2DM complications

    Time frame: During 3 years before baseline (0 to -36 months)

    Types of T2DM complications: Retinopathy, Diabetic neuropathy (peripheral, autonomic), Diabetic nephropathy, Amputation.

  5. Hospital appointments

    Time frame: During 3 years before baseline (0 to -36 months)

    Number of cardiology, ophthalmology, nephrology, and vascular surgery appointments

  6. Hospitalisation episodes

    Time frame: During 3 years before baseline (0 to -36 months)

    Number of episodes

  7. Emergency visits

    Time frame: During 3 years before baseline (0 to -36 months)

    Number of visits

  8. Change in waist circumference

    Time frame: During 3 years before baseline (0 to -36 months)

    Measured in cm

  9. Change in body mass index

    Time frame: During 3 years before baseline (0 to -36 months)

    Measured in kg/m^2

  10. Change in blood pressure

    Time frame: During 3 years before baseline (0 to -36 months)

    Measured in mmHg

  11. Change in urine albumin

    Time frame: During 3 years before baseline (0 to -36 months)

    Measured in mg/24 hours

  12. Change in urine albumin

    Time frame: During 3 years before baseline (0 to -36 months)

    Measured in microgram/minute

  13. Change in glycosylated hemoglobin (HbA1c)

    Time frame: During 3 years before baseline (0 to -36 months)

    Measured in mmol/mol

  14. Change in HbA1c

    Time frame: During 3 years before baseline (0 to -36 months)

    Measured in %

  15. Change in Estimated Glomerular Filtration Rate (eGFR)

    Time frame: During 3 years before baseline (0 to -36 months)

    Measured in mL/min/1.73 m^2

  16. Change in total cholesterol

    Time frame: During 3 years before baseline (0 to -36 months)

    measured in mg/dl

  17. Change in low-density lipoprotein cholesterol

    Time frame: During 3 years before baseline (0 to -36 months)

    measured in mg/dl

  18. Change in high-density lipoprotein cholesterol

    Time frame: During 3 years before baseline (0 to -36 months)

    measured in mg/dl

  19. Change in triglyceride

    Time frame: During 3 years before baseline (0 to -36 months)

    measured in mg/dl

  20. Type of pharmacological treatment

    Time frame: During 3 years before baseline (0 to -36 months)

    Types of pharmacological treatment: Antidiabetics Antihypertensive Lipid lowering therapy Antiplatelet/anticoagulant therapy

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Acronym: PICT2RE

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 9, 2019
Registry last updated
Nov 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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