Clinical trial NCT05563090: Investigating the Syndrome Differentiation of Diabetic and Pre-diabetic Using Digitalized TCM Diagnostic Tools
Official title: Investigating the Syndrome Differentiation of Diabetic and Pre-diabetic Patients in Singapore Using Digitalized TCM Diagnostic Tools: an Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabete Mellitus
Pre-diabetes
Healthy
Hypertension
Dyslipidemia Associated With Type II Diabetes Mellitus
Keywords: Diabetes Mellitus
Type II diabetes
Pre-diabetes
Healthy subjects
hypertension
dyslipidemia
TCM
TCM diagnosis
Pulse diagnosis
Tongue diagnosis
Lead sponsor: Singapore Chung Hwa Medical Institution
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Singapore
First posted: 2022-10-03
Enrollment: 171
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Detailed 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.

Eligibility criteria: 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' (脾胃虚弱)
* Subjects undergoing TCM treatment for diabetes or pre-diabetes within 1 week

Primary outcomes:
measure: The Constitution in Chinese Medicine Questionnaire (CCMQ)
timeFrame: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
measure: Physical Activity Questionnaire and sugar intake
timeFrame: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
measure: Pulse sphygmograph
timeFrame: One-time assessment within 30mins after undergoing the questionnaires
measure: Tongue imaging device
timeFrame: One-time assessment within 30mins after undergoing the questionnaires
Secondary outcomes:
measure: Health Evaluation - Age
timeFrame: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
measure: Health Evaluation - Gender
timeFrame: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
measure: Health Evaluation - Weight
timeFrame: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
measure: Health Evaluation - Height
timeFrame: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
measure: Health Evaluation - BMI
timeFrame: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
measure: Health Evaluation - blood sugar level
timeFrame: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
measure: Health Evaluation - Vital signs
timeFrame: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
measure: Health Evaluation - Radial pulse rate
timeFrame: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
measure: Health Evaluation - Medications
timeFrame: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
measure: Health Evaluation - Existing symptoms
timeFrame: One-time assessment within 30mins before undergoing the tongue and pulse diagnosis.
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore Chung Hwa Medical Institution
Study officials:
References: