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NCT01437072 Clinical Trial

Changing Diabetes® World Tour

Diabetes Mellitus, Type 2 Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01437072
Other study ID # INS-3934
Secondary ID U1111-1123-4683
Status Completed
Phase N/A
First received September 8, 2011
Last updated January 18, 2017
Start date November 2010
Est. completion date November 2011

Study information
Verified date January 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 8304
Est. completion date November 2011
Est. primary completion date November 2011
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No treatment given
The screening test includes a combination of a risk assessment questionnaire and biochemical tests.

Locations
Country Name City State
Portugal Novo Nordisk Investigational Site Paco de Arcos
Saudi Arabia Novo Nordisk Investigational Site Riyadh
United Arab Emirates Novo Nordisk Investigational Site Dubai

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Portugal,  Saudi Arabia,  United Arab Emirates, 

References & Publications (1)

Handlos LN, Witte DR, Almdal TP, Nielsen LB, Badawi SE, Sheikh AR, Belhadj M, Nadir D, Zinai S, Vistisen D. Risk scores for diabetes and impaired glycaemia in the Middle East and North Africa. Diabet Med. 2013 Apr;30(4):443-51. doi: 10.1111/dme.12118. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c (Glycosylated Haemoglobin) level measured at the screening visit (only 1 visit during the 2 weeks stay of the bus in each country)
Secondary Number of subjects with diabetes (type 1 and 2) measured at the screening visit (only 1 visit during the 2 weeks stay of the bus in each country)
Secondary The presence of retinopathy measured at the screening visit (only 1 visit during the 2 weeks stay of the bus in each country)
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