An observational study in Diabete Mellitus, Pre-diabetes and Healthy, sponsored by Singapore Chung Hwa Medical Institution. Completed at 1 site in Singapore. Open to participants aged 21 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-04.
Sponsored by Singapore Chung Hwa Medical Institution · Observational
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.
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.
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This study's enrollment of 171 is below the median of 210 across 1,359 observational studies indexed under Hypertension.
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The subjects need to be at 21-75 years old, of either gender, with no limitations on race, and is clinically diagnosed by Western medical doctors with either diabetes (FPG of ≥ 7.0 mmol/L, 2hPG of ≥ 11.1mmol, or HbA1c of > 6.5%) or prediabetes (IFG of FPG 6.1-6.9 mmol/L, and/or IGT with 2hPG of 7.8-11.0 mmol/L). Healthy or sub-healthy subjects without any significant health related issues, eg. clinically diagnosed chronic conditions such as diabetes, hypertension or dyslipidemia, will be recruited as the control group. The health evaluation form (Annex 1) will be used to verify that these healthy subjects (1) do not have any family history of diabetes, and (2) do not have unusual high fasting blood glucose detected within one year.
Clinically diagnosed with one of the following:
Exclusion Criteria:
Healthy or sub-healthy subject without clinically diagnosed chronic conditions such as diabetes, hypertension or dyslipidemia
Other: Questionnaires+Tongue diagnosis+Pulse diagnosis
Prediabetes with IFG of FPG 6.1-6.9 mmol/L, and/or IGT with 2hPG of 7.8-11.0 mmol/L
Other: Questionnaires+Tongue diagnosis+Pulse diagnosis
Diabetes with FPG of ≥ 7.0 mmol/L, 2hPG of ≥ 11.1mmol, or HbA1c of \> 6.5%
Other: Questionnaires+Tongue diagnosis+Pulse diagnosis
Prediabetes with hypertension and dyslipidemia
Other: Questionnaires+Tongue diagnosis+Pulse diagnosis
Diabetes with hypertension and dyslipidemia
Other: Questionnaires+Tongue diagnosis+Pulse diagnosis
Each subject will undergo questionnaires, tongue and pulse diagnosis using modern diagnostic tools
The Constitution in Chinese Medicine Questionnaire (CCMQ)
The CCMQ, published by the China Association of Chinese Medicine in 2009, will be adopted to assess the body constitution of each subjects based on TCM principles \[26\]. Refer to Annex 3. There are nine different types of body constitution, including (a) Normality; (b) Qi deficiency; (c) Yin deficiency; (d) Yang deficiency; (e) Phlegm-dampness; (f) Damp-heat; (g) Blood stasis; (h) Qi depressed; (i) Inherited special constitution. Each subject will answer seven to eight questions in each category. The scoring algorithm indicates the likelihood of a specific type of body constitution with a higher score.
Time frame: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
Physical Activity Questionnaire and sugar intake
Level of physical activity related to the last three months will be recorded through the Physical Activity Questionnaire. Sugar intake includes sweet or carbonated drinks, desserts like chocolates and cakes, 0 - 2, 3 - 6, or more than 7 times a week will also be recorded. Refer to Annex 2. This will help to identify the risk factors involved and identify the correlation between the body constitutions and various types of 'xiao-ke' based on TCM syndrome differentiation.
Time frame: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
Pulse sphygmograph
The Asia Plus Pen Pulse Analysis System Model PPAS-93 (Asia Plus Bio Tech Co., Ltd, Taiwan) would be used in the identification of RPPW of the subjects in this study. The Asia Plus Pen Pulse Analysis System Model PPAS-93 (Figure 11) is a noninvasive device that consist of a high precision pressure sensor pen and a pulse analyzer. The 3D pulse detector is a handheld pen that digitalizes the biological signal of RPPW and provides a graphical analysis. The electronic device contains a high precision pressure sensor, a filter, an amplifier, and a signal recording card connected to signal analysis software. The frequency response is 0.1-50 Hz, and the sampling rate is 3000 Hz.
Time frame: One-time assessment within 30mins after undergoing the questionnaires
Tongue imaging device
China Artificial Intelligence Health Status Identification System Model Number YZKJ-SMZY-1AI (Figure 12) will be used in the imaging and analysis of the subject's tongue. The noninvasive device captures the image of the tongue through an inbuilt camera supported by LED lights within the device. A monitor that is connected to the imaging device would provide a live video feedback on the positioning of the tongue. The images of the subjects' face, tongue, and sublingual collaterals will then be compared and analyzed for the similarities against standard images of tongue analysis using an artificial intelligence system.
Time frame: One-time assessment within 30mins after undergoing the questionnaires
Health Evaluation - Age
Demographic information eg age in years will be collected.
Time frame: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
Health Evaluation - Gender
Demographic information eg gender will be collected.
Time frame: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
Health Evaluation - Weight
Weight in kilogram will be recorded
Time frame: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
Health Evaluation - Height
Height in meters will be recorded
Time frame: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
Health Evaluation - BMI
Weight in kilogram and height in meters will be aggregated to derive the BMI in kg/m\^2.
Time frame: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
Health Evaluation - blood sugar level
Blood glucose in fasting, 2hPG or HbA1c (in mmol/L) results if available in patient's regular blood test report
Time frame: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
Health Evaluation - Vital signs
Vital signs including systolic blood pressure, diastolic blood pressure in mmHg
Time frame: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
Health Evaluation - Radial pulse rate
Vital signs including radial pulse rate (bpm)
Time frame: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
Health Evaluation - Medications
Western and Chinese medications and nutritional supplements consumed by the subjects will be recorded to identify possible intervention and correlation towards TCM syndrome differentiation.
Time frame: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
Health Evaluation - Existing symptoms
The existing symptoms of subjects will be recorded to identify the possible correlation towards TCM syndrome differentiation.
Time frame: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
Plan to share: Undecided
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Singapore Chung Hwa Medical Institution