An International Survey of the Occurrence of Diseases That Affects the Heart and Blood Vessels Among People With Type 2 Diabetes

NCT ID: NCT03786406

Last Updated: 2023-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2275 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-03

Study Completion Date

2019-05-31

Brief Summary

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The purpose of the study is to register the occurrence of cardiovascular disease among type 2 diabetes (T2DM) patients across five selected countries in Europe. 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 what has been prescribed to them by their doctor. Participants' participation will be one day/one visit at study doctor. The study will last for about 3 months in total.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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T2DM patients seen in routine practice

All anti-diabetic and cardiovascular (CV) medication will be prescribed at the physician's discretion under routine clinical practice conditions.

No treatment given

Intervention Type 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.

Interventions

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No treatment given

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

Intervention Type OTHER

Eligibility Criteria

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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 greater than or equal to 18 years at the time of signing informed consent
* Diagnosed with type 2 diabetes mellitus greater 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Reporting Anchor and Disclosure (1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Benátky nad Jizerou, , Czechia

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Novo Nordisk Investigational Site

Boskovice, , Czechia

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Novo Nordisk Investigational Site

Brandýs nad Labem, , Czechia

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Novo Nordisk Investigational Site

Břeclav, , Czechia

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Novo Nordisk Investigational Site

Chomutov, , Czechia

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Novo Nordisk Investigational Site

Hradec Králové, , Czechia

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Novo Nordisk Investigational Site

Kroměříž, , Czechia

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Olomouc, , Czechia

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Novo Nordisk Investigational Site

Orlová, , Czechia

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Ostrava, , Czechia

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Ostrava, , Czechia

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Pilsen, , Czechia

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Prague, , Czechia

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Chartres, , France

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Courpière, , France

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Le Creusot, , France

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Lyon, , France

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Montélimar, , France

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Saint-Saëns, , France

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Sathonay-Camp, , France

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Strasbourg, , France

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Tarare, , France

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Vénissieux, , France

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Albano Laziale, , Italy

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Ariano Irpino, , Italy

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Bagno a Ripoli, , Italy

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Brindisi, , Italy

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Catanzaro, , Italy

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Fano, , Italy

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Ferrara, , Italy

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Florence, , Italy

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Messina, , Italy

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Milan, , Italy

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Napoli, , Italy

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Negrar (VR), , Italy

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Orvieto, , Italy

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Partinico (PA), , Italy

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Ravenna, , Italy

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Novo Nordisk Investigational Site

Roma, , Italy

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Novo Nordisk Investigational Site

Rozzano (MI), , Italy

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Novo Nordisk Investigational Site

Savigliano (CN), , Italy

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Countries

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Czechia France Italy

References

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Mosenzon O, Alguwaihes A, Leon JLA, Bayram F, Darmon P, Davis TME, Dieuzeide G, Eriksen KT, Hong T, Kaltoft MS, Lengyel C, Rhee NA, Russo GT, Shirabe S, Urbancova K, Vencio S; CAPTURE Study Investigators. CAPTURE: a multinational, cross-sectional study of cardiovascular disease prevalence in adults with type 2 diabetes across 13 countries. Cardiovasc Diabetol. 2021 Jul 27;20(1):154. doi: 10.1186/s12933-021-01344-0.

Reference Type RESULT
PMID: 34315481 (View on PubMed)

Vencio S, Vianna AGD, da Silva MACF, Precoma DB. Contemporary (2019) prevalence of cardiovascular disease in adults with type 2 diabetes in Brazil: the cross-sectional CAPTURE study. Diabetol Metab Syndr. 2022 Jan 10;14(1):5. doi: 10.1186/s13098-021-00775-9.

Reference Type DERIVED
PMID: 35012646 (View on PubMed)

Other Identifiers

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U1111-1207-2816

Identifier Type: OTHER

Identifier Source: secondary_id

NN2211-4423

Identifier Type: -

Identifier Source: org_study_id

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