An International Survey of the Occurrence of Cardiovascular Disease Among Patients With Type 2 Diabetes

The purpose of the study is to register the occurrence of cardiovascular disease among type 2 diabetes patients across ten countries across the world. Participants will be asked to give information about their health. Participants will continue their normal way of life and will not get any medication other than prescribed to them by their doctor. Participants' participation will be one day/one visit at their doctor. The study will last for about 6 months in total.

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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, Algiers, Algeria

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Signed informed consent obtained before any study-related activities (study-related activities are any procedures related to recording of data according to protocol)
Male or female, age more than or equal to 18 years at the time of signing informed consent (in Algeria more than or equal to 19 years; in Japan more than or equal to 20 years).
Diagnosed with T2DM more than or equal to 180 days prior to the day of signing the informed consent

Exclusion criteria

Previous participation in this study. Participation is defined as having given informed consent in this study
Diagnosed with Type 1 diabetes
Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
Patients with known congenital heart disease/malformation

Treatment and study plan

No treatment given

Other

No specific intervention is studied. All anti-diabetic and CV medication will be prescribed at the physician's discretion under routine clinical practice conditions.

Primary outcomes

Participants with a history of established cardiovascular disease (CVD)

Time frame: Day 1

Participants having a history of established CVD, i.e. who have been diagnosed with any one of the following listed conditions (yes/no): Cerebrovascular disease, cardiovascular disease, symptomatic heart failure, asymptomatic heart failure, hospitalisation for heart failure, cardiac arrhythmia, aortic disease, peripheral artery disease or carotid artery disease.

Secondary outcomes

Participants with high risk of CVD according to the risk engine from the United Kingdom Prospective Diabetes Study (UKPDS)

Time frame: Day 1

Percentage of participants (yes/no). High risk: more than 20 percent over 10 years.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Non-interventional Cross-sectional Study to Capture the Prevalence of Cardiovascular Disease in Patients With Type 2 Diabetes - an International Observation

Acronym: CAPTURE-IO

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Jan 22, 2019
Registry last updated: Jun 9, 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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Completed