Investigation of CYP1A2 drug metabolism activity in Europeans and South Asians

Not Applicable

Completed

• Conditions: The study is looking at ethnic differences in metabolic activity of CYP1A2 between people of European and South Asian Ancestry; Metabolic and Endocrine - Normal metabolism and endocrine development and function

• Registration Number: ACTRN12610000169044
• Lead Sponsor: THe University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-02-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Only those people of European and South Asian ancestry can take part in this study. Ethnicity of a person will be assigned based on the ethnicity of a person’s four grandparents (i.e. all four grandparents need to be of the same ethnicity and have the same country of birth).

Exclusion Criteria

Subjects who will be excluded from the study include if they are
Under 18 years of age,
suffering from an acute illness (hospitalised),
pregnant or breast-feeding women, and
being too ill (or where illness compromises the ability to produce uncontaminated saliva (e.g. gum disease such as gingivitis)).
not able to understand English

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compare the CYP1A2 activity of South Asians and Europeans using the 4 h paraxanthine/caffeine concentration ratio in saliva[THe outcomes measured will be after recruitment which will take one year]

Secondary Outcome Measures

Name	Time	Method
Correlate the CYP1A2 activity of all subjects to CYP1A2 polymorphisms for the total cohort and after stratifying by ethnicity.<br><br>When stratifying groups into SOuth Asian and European, independent samples t-test will be used to assess differences. For more than two groups ANOVA will be used. Calculations will be conducted using excel 2003-2007 and Statistical Packages for the Social Sciences (SPSS) V 16.0[THe outcomes measured will be after recruitment which will take one year];Correlate dietary/lifestyle factors with CYP1A2 activity;<br><br>Linear regression will be used to assess factors which affect CYP1A2 activity. Calculations will be conducted using excel 2003-2007 and Statistical Packages for the Social Sciences (SPSS) V 16.0[THe outcomes measured will be after recruitment which will take one year]