Clinical trial NCT03811288: An International Survey of the Occurrence of Cardiovascular Disease Among Patients With Type 2 Diabetes
Official title: A Non-interventional Cross-sectional Study to Capture the Prevalence of Cardiovascular Disease in Patients With Type 2 Diabetes - an International Observation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2019-01-22
Enrollment: 7548
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of male and female adults diagnosed with T2DM.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Participants with a history of established cardiovascular disease (CVD)
timeFrame: Day 1
Secondary outcomes:
measure: Participants with high risk of CVD according to the risk engine from the United Kingdom Prospective Diabetes Study (UKPDS)
timeFrame: Day 1
Other outcomes:
Locations:
city: Algiers
country: Algeria
facility: Novo Nordisk Investigational Site
city: Batna
country: Algeria
facility: Novo Nordisk Investigational Site
city: Constantine
country: Algeria
facility: Novo Nordisk Investigational Site
city: Tiaret
country: Algeria
facility: Novo Nordisk Investigational Site
city: Tizi Ouzou
country: Algeria
facility: Novo Nordisk Investigational Site
city: Buenos Aires
country: Argentina
facility: Novo Nordisk Investigational Site
city: Buenos Aires
country: Argentina
facility: Novo Nordisk Investigational Site
city: Buenos Aires
country: Argentina
facility: Novo Nordisk Investigational Site
city: Buenos Aires
country: Argentina
facility: Novo Nordisk Investigational Site
city: Caba
country: Argentina
facility: Novo Nordisk Investigational Site
city: Caba
country: Argentina
facility: Novo Nordisk Investigational Site
city: Caba
country: Argentina
facility: Novo Nordisk Investigational Site
city: Chacabuco
country: Argentina
facility: Novo Nordisk Investigational Site
city: Cordoba
country: Argentina
facility: Novo Nordisk Investigational Site
city: Coronel Suarez
country: Argentina
facility: Novo Nordisk Investigational Site
city: Córdoba
country: Argentina
facility: Novo Nordisk Investigational Site
city: Córdoba
country: Argentina
facility: Novo Nordisk Investigational Site
city: Córdoba
country: Argentina
facility: Novo Nordisk Investigational Site
city: Godoy Cruz
country: Argentina
facility: Novo Nordisk Investigational Site
city: Lanus Este
country: Argentina
facility: Novo Nordisk Investigational Site
city: Mar del Plata
country: Argentina
facility: Novo Nordisk Investigational Site
city: Mar del Plata
country: Argentina
facility: Novo Nordisk Investigational Site
city: Morón
country: Argentina
facility: Novo Nordisk Investigational Site
city: Blacktown
country: Australia
facility: Novo Nordisk Investigational Site
state: New South Wales
city: Brookvale
country: Australia
facility: Novo Nordisk Investigational Site
state: New South Wales
city: Campbelltown
country: Australia
facility: Novo Nordisk Investigational Site
state: New South Wales
city: Coffs Harbour
country: Australia
facility: Novo Nordisk Investigational Site
state: New South Wales
city: Maroubra
country: Australia
facility: Novo Nordisk Investigational Site
state: New South Wales
city: Wollongong
country: Australia
facility: Novo Nordisk Investigational Site
state: New South Wales
city: Herston
country: Australia
facility: Novo Nordisk Investigational Site
state: Queensland
city: Morayfield
country: Australia
facility: Novo Nordisk Investigational Site
state: Queensland
city: North Ipswich
country: Australia
facility: Novo Nordisk Investigational Site
state: Queensland
city: Sherwood
country: Australia
facility: Novo Nordisk Investigational Site
state: Queensland
city: Victoria Point
country: Australia
facility: Novo Nordisk Investigational Site
state: Queensland
city: Forest Hill
country: Australia
facility: Novo Nordisk Investigational Site
state: Victoria
city: Moonee Ponds
country: Australia
facility: Novo Nordisk Investigational Site
state: Victoria
city: Parkville
country: Australia
facility: Novo Nordisk Investigational Site
state: Victoria
city: Preston
country: Australia
facility: Novo Nordisk Investigational Site
state: Victoria
city: Ringwood
country: Australia
facility: Novo Nordisk Investigational Site
state: Victoria
city: Fremantle
country: Australia
facility: Novo Nordisk Investigational Site
state: Western Australia
city: Geelong
country: Australia
facility: Novo Nordisk Investigational Site
city: Fortaleza
country: Brazil
facility: Novo Nordisk Investigational Site
state: Ceara
city: Aparecida de Goiania
country: Brazil
facility: Novo Nordisk Investigational Site
state: Goias
city: Goiânia
country: Brazil
facility: Novo Nordisk Investigational Site
state: Goias
city: Belo Horizonte
country: Brazil
facility: Novo Nordisk Investigational Site
state: Minas Gerais
city: Belo Horizonte
country: Brazil
facility: Novo Nordisk Investigational Site
state: Minas Gerais
city: Uberaba
country: Brazil
facility: Novo Nordisk Investigational Site
state: Minas Gerais
city: Campina Grande do Sul
country: Brazil
facility: Novo Nordisk Investigational Site
state: Parana
city: Curitiba
country: Brazil
facility: Novo Nordisk Investigational Site
state: Parana
city: Curitiba
country: Brazil
facility: Novo Nordisk Investigational Site
state: Parana
city: Maringa
country: Brazil
facility: Novo Nordisk Investigational Site
state: Parana
city: Maringa
country: Brazil
facility: Novo Nordisk Investigational Site
state: Parana
city: Passo Fundo
country: Brazil
facility: Novo Nordisk Investigational Site
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Novo Nordisk Investigational Site
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Novo Nordisk Investigational Site
state: Rio Grande Do Sul
city: Campinas
country: Brazil
facility: Novo Nordisk Investigational Site
state: Sao Paulo
city: Santo André
country: Brazil
facility: Novo Nordisk Investigational Site
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Novo Nordisk Investigational Site
state: Sao Paulo
city: Tatui
country: Brazil
facility: Novo Nordisk Investigational Site
state: Sao Paulo
city: Votuporanga
country: Brazil
facility: Novo Nordisk Investigational Site
state: Sao Paulo
city: Fortaleza
country: Brazil
facility: Novo Nordisk Investigational Site
city: Sao Paulo
country: Brazil
facility: Novo Nordisk Investigational Site
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: Lanzhou
country: China
facility: Novo Nordisk Investigational Site
state: Gansu
city: Guangzhou
country: China
facility: Novo Nordisk Investigational Site
state: Guangdong
city: Guiyang
country: China
facility: Novo Nordisk Investigational Site
state: Guizhou
city: Wuxi
country: China
facility: Novo Nordisk Investigational Site
state: Jiangsu
city: Shanghai
country: China
facility: Novo Nordisk Investigational Site
state: Shanghai
city: Luzhou
country: China
facility: Novo Nordisk Investigational Site
state: Sichuan
city: Nanchong
country: China
facility: Novo Nordisk Investigational Site
state: Sichuan
city: Ningbo
country: China
facility: Novo Nordisk Investigational Site
state: Zhejiang
city: Nanjing
country: China
facility: Novo Nordisk Investigational Site
city: Bat Yam
country: Israel
facility: Novo Nordisk Investigational Site
city: Beer sheva
country: Israel
facility: Novo Nordisk Investigational Site
city: Beer-Sheva HaDarom
country: Israel
facility: Novo Nordisk Investigational Site
city: Bnei Brak
country: Israel
facility: Novo Nordisk Investigational Site
city: Haifa
country: Israel
facility: Novo Nordisk Investigational Site
city: Holon
country: Israel
facility: Novo Nordisk Investigational Site
city: Jerusalem
country: Israel
facility: Novo Nordisk Investigational Site
city: Jerusalem
country: Israel
facility: Novo Nordisk Investigational Site
city: Kiryat Bialik
country: Israel
facility: Novo Nordisk Investigational Site
city: Nahariya
country: Israel
facility: Novo Nordisk Investigational Site
city: Nazareth
country: Israel
facility: Novo Nordisk Investigational Site
city: Petach Tikva
country: Israel
facility: Novo Nordisk Investigational Site
city: Petah-Tikva
country: Israel
facility: Novo Nordisk Investigational Site
city: Ra'anana
country: Israel
facility: Novo Nordisk Investigational Site
city: Tel Aviv
country: Israel
facility: Novo Nordisk Investigational Site
city: Tel-Aviv
country: Israel
facility: Novo Nordisk Investigational Site
city: Zefat
country: Israel
facility: Novo Nordisk Investigational Site
city: Chiba-shi, Chiba
country: Japan
facility: Novo Nordisk Investigational Site
city: Chuo-ku, Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Ebina-shi, Kanagawa
country: Japan
facility: Novo Nordisk Investigational Site
city: Fukushima
country: Japan
facility: Novo Nordisk Investigational Site
city: Hamamatsu-Shi Shizuoka
country: Japan
facility: Novo Nordisk Investigational Site
city: Hokkaido
country: Japan
facility: Novo Nordisk Investigational Site
city: Kanagawa
country: Japan
facility: Novo Nordisk Investigational Site
city: Kawagoe-shi, Saitama
country: Japan
facility: Novo Nordisk Investigational Site
city: Koshigaya-shi,Saitama
country: Japan
facility: Novo Nordisk Investigational Site
city: Kumamoto
country: Japan
facility: Novo Nordisk Investigational Site
city: Mito-shi, Ibaraki
country: Japan
facility: Novo Nordisk Investigational Site
city: Miyazaki
country: Japan
facility: Novo Nordisk Investigational Site
city: Nishi-ku Sapporo
country: Japan
facility: Novo Nordisk Investigational Site
city: Oita-shi
country: Japan
facility: Novo Nordisk Investigational Site
city: Okawa-shi, Fukuoka
country: Japan
facility: Novo Nordisk Investigational Site
city: Ota-ku, Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Oyama-shi
country: Japan
facility: Novo Nordisk Investigational Site
city: Shimotsuke-shi, Tochigi
country: Japan
facility: Novo Nordisk Investigational Site
city: Shinjyuku-ku Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Tijuana
country: Mexico
facility: Novo Nordisk Investigational Site
state: Baja California Norte
city: Monclova
country: Mexico
facility: Novo Nordisk Investigational Site
state: Coahuila
city: Mexico
country: Mexico
facility: Novo Nordisk Investigational Site
state: Estado De México
city: Celaya
country: Mexico
facility: Novo Nordisk Investigational Site
state: Guanajuato
city: León
country: Mexico
facility: Novo Nordisk Investigational Site
state: Guanajuato
city: Acapulco de Juarez
country: Mexico
facility: Novo Nordisk Investigational Site
state: Guerrero
city: Guadalajara
country: Mexico
facility: Novo Nordisk Investigational Site
state: Jalisco
city: Guadalajara
country: Mexico
facility: Novo Nordisk Investigational Site
state: Jalisco
city: Guadalajara
country: Mexico
facility: Novo Nordisk Investigational Site
state: Jalisco
city: Guadalajara
country: Mexico
facility: Novo Nordisk Investigational Site
state: Jalisco
city: Puerto Vallarta
country: Mexico
facility: Novo Nordisk Investigational Site
state: Jalisco
city: Zapopan
country: Mexico
facility: Novo Nordisk Investigational Site
state: Jalisco
city: Zapopan
country: Mexico
facility: Novo Nordisk Investigational Site
state: Jalisco
city: Cuernavaca
country: Mexico
facility: Novo Nordisk Investigational Site
state: Morelos
city: Benito Juárez
country: Mexico
facility: Novo Nordisk Investigational Site
state: México, D.F.
city: Cuauhtemoc
country: Mexico
facility: Novo Nordisk Investigational Site
state: México, D.F.
city: Gustavo A Madero
country: Mexico
facility: Novo Nordisk Investigational Site
state: México, D.F.
city: Mexico City
country: Mexico
facility: Novo Nordisk Investigational Site
state: México, D.F.
city: Monterrey
country: Mexico
facility: Novo Nordisk Investigational Site
state: Nuevo León
city: Monterrey
country: Mexico
facility: Novo Nordisk Investigational Site
state: Nuevo León
city: San Luis Potosí
country: Mexico
facility: Novo Nordisk Investigational Site
state: San Luis Potosi
city: Culiacán
country: Mexico
facility: Novo Nordisk Investigational Site
state: Sinaloa
city: Hermosillo
country: Mexico
facility: Novo Nordisk Investigational Site
state: Sonora
city: Ciudad Madero
country: Mexico
facility: Novo Nordisk Investigational Site
state: Tamaulipas
city: Aguascalientes
country: Mexico
facility: Novo Nordisk Investigational Site
city: Guadalajara
country: Mexico
facility: Novo Nordisk Investigational Site
city: Mexico City
country: Mexico
facility: Novo Nordisk Investigational Site
city: Monterrey
country: Mexico
facility: Novo Nordisk Investigational Site
city: Queretaro
country: Mexico
facility: Novo Nordisk Investigational Site
city: San Luis Potosi
country: Mexico
facility: Novo Nordisk Investigational Site
city: Veracruz
country: Mexico
facility: Novo Nordisk Investigational Site
city: Al Ihsa
country: Saudi Arabia
facility: Novo Nordisk Investigational Site
city: Buraydah
country: Saudi Arabia
facility: Novo Nordisk Investigational Site
city: Jeddah
country: Saudi Arabia
facility: Novo Nordisk Investigational Site
city: Riyadh
country: Saudi Arabia
facility: Novo Nordisk Investigational Site
city: Riyadh
country: Saudi Arabia
facility: Novo Nordisk Investigational Site
city: Riyadh
country: Saudi Arabia
facility: Novo Nordisk Investigational Site
city: Taif
country: Saudi Arabia
facility: Novo Nordisk Investigational Site
city: Adana
country: Turkey
facility: Novo Nordisk Investigational Site
city: Ankara
country: Turkey
facility: Novo Nordisk Investigational Site
city: Ankara
country: Turkey
facility: Novo Nordisk Investigational Site
city: Ankara
country: Turkey
facility: Novo Nordisk Investigational Site
city: Antalya
country: Turkey
facility: Novo Nordisk Investigational Site
city: Edirne
country: Turkey
facility: Novo Nordisk Investigational Site
city: Elazig
country: Turkey
facility: Novo Nordisk Investigational Site
city: Eskisehir
country: Turkey
facility: Novo Nordisk Investigational Site
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
city: Izmir
country: Turkey
facility: Novo Nordisk Investigational Site
city: Kayseri
country: Turkey
facility: Novo Nordisk Investigational Site
city: Malatya
country: Turkey
facility: Novo Nordisk Investigational Site
city: Tekirdag
country: Turkey
facility: Novo Nordisk Investigational Site
city: Zonguldak
country: Turkey
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.