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OpenTrials
Completed

NCT Number: NCT01437072

Changing Diabetes® World Tour

This study is conducted in the Middle East, Northern Africa and Europe. The aim of this study is to contribute to the design of a simple screening strategy for countries in scope, by exploring the association between risk factors and undiagnosed diabetes in a screening study.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site, Paço de Arcos, Portugal

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Informed consent obtained

Exclusion criteria

  • Subjects with known diabetes (exception: women with a history of gestational diabetes should not be excluded)
  • Pregnant women or women who have given birth within less than a month
  • Subjects suffering from severe illness
  • Subjects with the inability to read and understand the information given (either due to illiteracy or vision problems) and therefore unable to give an informed consent
  • Subjects with mental impairment
  • Subjects treated with systemic cortico-steroids

Treatment and study plan

No treatment given

Other

The screening test includes a combination of a risk assessment questionnaire and biochemical tests.

Primary outcomes

  1. HbA1c (Glycosylated Haemoglobin) level

    Time frame: measured at the screening visit (only 1 visit during the 2 weeks stay of the bus in each country)

Secondary outcomes

  1. Number of subjects with diabetes (type 1 and 2)

    Time frame: measured at the screening visit (only 1 visit during the 2 weeks stay of the bus in each country)

  2. The presence of retinopathy

    Time frame: measured at the screening visit (only 1 visit during the 2 weeks stay of the bus in each country)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Changing Diabetes® World Tour a Study on the Association of Risk Factors and the Presence of Undiagnosed Diabetes in the Middle East, Northern Africa and Europe

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 20, 2011
Registry last updated
Jan 19, 2017

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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