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Clinical Trial Summary

The investigators aim to objectively identify the Traditional Chinese Medicine (TCM) syndrome differentiation of type II diabetic and prediabetic patients in Singapore through modern technologies thereby potentially increasing the accuracy of identification, diagnosis, and prevention of diabetes and prediabetes through a system of targeted treatment. This observational study integrates the concept of TCM diagnostic methods with modern tools aim to provide an objective view on the syndrome differentiation of diabetic and prediabetic patients in Singapore and hence provide a guideline in the treatment options targeted specifically at Singaporeans demographic. A total of 250 subjects with 50 allocated in each group will be recruited to ensure a sufficient sample size for statistical analysis of the diabetic and prediabetic syndrome differentiation. Subjects aged 21-65 years old, of either gender, with no limitations on race, and is diagnosed with either diabetes (FPG ≥ 7.0 mmol/L, or 2hPG ≥ 11.1mmol) or prediabetes (IFG of FPG 6.1-6.9 mmol/L, and/or IGT with 2hPG of 7.8-11.0 mmol/L) will be included. Subjective and objective assessments through health evaluation, Physical Activity Questionnaire and Sugar Intake, Constitution in Chinese Medicine Questionnaire, radial pulse diagnosis and tongue diagnosis will be performed for each subject in a single visit. Statistical analysis of assessments will be conducted using unpaired t-test with significance level of p<0.05. Statistical software SPSS 15.0 (SPSS Inc.) will be used for the analysis.


Clinical Trial Description

Singapore's age-adjusted comparative prevalence of diabetes is at 5.5% in 2019 down from 10.2% in 2010, whereas the global average is at 8.3%. However, approximately 640,000 Singapore citizens 18 years and above are diagnosed with diabetes, and around 650,000 citizens are prediabetic. The investigators aim to objectively identify the Traditional Chinese Medicine (TCM) syndrome differentiation of type II diabetic and prediabetic patients in Singapore through modern technologies thereby potentially increasing the accuracy of identification, diagnosis, and prevention of diabetes and prediabetes through a system of targeted treatment. The investigators hypothesize that the TCM syndrome differentiation of 'xiao-ke' in Singapore is different from that of the ones defined in TCM Internal Medicine, which is based on China demographics. This observational study integrates the concept of TCM diagnostic methods with modern tools aim to provide an objective view on the syndrome differentiation of diabetic and prediabetic patients in Singapore and hence provide a guideline in the treatment options targeted specifically at Singaporeans demographic. The investigators will attempt to recruit a total of 250 subjects with 50 allocated in each group to ensure a sufficient sample size for statistical analysis of the diabetic and prediabetic syndrome differentiation. Subjects aged 21-75 years old, of either gender, with no limitations on race, and is diagnosed with either diabetes (FPG ≥ 7.0 mmol/L, or 2hPG ≥ 11.1mmol) or prediabetes (IFG of FPG 6.1-6.9 mmol/L, and/or IGT with 2hPG of 7.8-11.0 mmol/L) will be included. Subjective and objective assessments through health evaluation, Physical Activity Questionnaire and Sugar Intake, Constitution in Chinese Medicine Questionnaire, radial pulse diagnosis and tongue diagnosis will be performed for each subject in a single visit. Statistical analysis of assessments will be conducted using unpaired t-test with significance level of p<0.05. Statistical software SPSS 15.0 (SPSS Inc.) will be used for the analysis. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05563090
Study type Observational
Source Singapore Chung Hwa Medical Institution
Contact Hui Ping Ng, MD
Phone 98759418
Email huanghuiping@singaporetcm.com
Status Recruiting
Phase
Start date September 17, 2022
Completion date December 31, 2024

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