Investigating the Syndrome Differentiation of Diabetic and Pre-diabetic Using Digitalized TCM Diagnostic Tools

Healthy Clinical Trial

Official title:

Investigating the Syndrome Differentiation of Diabetic and Pre-diabetic Patients in Singapore Using Digitalized TCM Diagnostic Tools: an Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05563090
• Other study ID #: SCHMI-2022-001
• Status: Recruiting
• Start date: September 17, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: Singapore Chung Hwa Medical Institution
• Contact: Hui Ping Ng, MD
• Phone: 98759418
• Email: huanghuiping[@]singaporetcm.com
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

Inclusion Criteria:

• Aged 21-75 years old, inclusive;

• Clinically diagnosed with one of the following:

1. Type II Diabetes Mellitus with or without hypertension and dyslipidemia

2. Prediabetes with or without hypertension and dyslipidemia

3. Healthy or sub-healthy subject without clinically diagnosed chronic conditions such as diabetes, hypertension or dyslipidemia

Exclusion Criteria:

• Subjects diagnosed with Gestational Diabetes

• Subjects who are pregnant or lactating

• Subjects with chronic heart failure, history of carcinomas with treatment of chemotherapy/radiotherapy, psychological, or psychiatric disorders

• Subjects with heart diseases and transplanted devices such as pacemakers;

• Subjects with acute infections such as upper respiratory infections, acute gastroenteritis, or urinary tract infections;

• Subjects unable to undergo evaluation with the pulse sphygmograph, tongue detection or complete the questionnaire;

• Subjects with communication disorders

• Subjects with gastroenterology diseases or are diagnosed with 'spleen and stomach deficiency' (????)

• Subjects undergoing TCM treatment for diabetes or pre-diabetes within 1 week

Related Conditions & MeSH terms

• Diabete Mellitus
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Dyslipidemia Associated With Type II Diabetes Mellitus
• Dyslipidemias
• Glucose Intolerance
• Healthy
• Hypertension
• Pre-diabetes
• Prediabetic State

Intervention

Other:
• Questionnaires+Tongue diagnosis+Pulse diagnosis
Each subject will undergo questionnaires, tongue and pulse diagnosis using modern diagnostic tools

Locations

Country	Name	City	State
Singapore	Singapore Chung Hwa Medical Institution	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Singapore Chung Hwa Medical Institution	Ministry of Health, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
Primary	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.	One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
Primary	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.	One-time assessment within 30mins after undergoing the questionnaires
Primary	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.	One-time assessment within 30mins after undergoing the questionnaires
Secondary	Health Evaluation - Age	Demographic information eg age in years will be collected.	One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
Secondary	Health Evaluation - Gender	Demographic information eg gender will be collected.	One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
Secondary	Health Evaluation - Weight	Weight in kilogram will be recorded	One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
Secondary	Health Evaluation - Height	Height in meters will be recorded	One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
Secondary	Health Evaluation - BMI	Weight in kilogram and height in meters will be aggregated to derive the BMI in kg/m^2.	One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
Secondary	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	One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
Secondary	Health Evaluation - Vital signs	Vital signs including systolic blood pressure, diastolic blood pressure in mmHg	One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
Secondary	Health Evaluation - Radial pulse rate	Vital signs including radial pulse rate (bpm)	One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
Secondary	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.	One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
Secondary	Health Evaluation - Existing symptoms	The existing symptoms of subjects will be recorded to identify the possible correlation towards TCM syndrome differentiation.	One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.