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

NCT ID: NCT05563090

Last Updated: 2025-05-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 171 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-17
• Study Completion Date: 2025-04-01

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.

Conditions

Diabete Mellitus; Pre-diabetes; Healthy; Hypertension; Dyslipidemia Associated With Type II Diabetes Mellitus

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

0HEA

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

Questionnaires+Tongue diagnosis+Pulse diagnosis

Intervention Type: OTHER

Each subject will undergo questionnaires, tongue and pulse diagnosis using modern diagnostic tools

1PRE

Prediabetes with IFG of FPG 6.1-6.9 mmol/L, and/or IGT with 2hPG of 7.8-11.0 mmol/L

Questionnaires+Tongue diagnosis+Pulse diagnosis

Intervention Type: OTHER

Each subject will undergo questionnaires, tongue and pulse diagnosis using modern diagnostic tools

2DIA

Diabetes with FPG of ≥ 7.0 mmol/L, 2hPG of ≥ 11.1mmol, or HbA1c of \> 6.5%

Questionnaires+Tongue diagnosis+Pulse diagnosis

Intervention Type: OTHER

Each subject will undergo questionnaires, tongue and pulse diagnosis using modern diagnostic tools

3PREHD

Prediabetes with hypertension and dyslipidemia

Questionnaires+Tongue diagnosis+Pulse diagnosis

Intervention Type: OTHER

Each subject will undergo questionnaires, tongue and pulse diagnosis using modern diagnostic tools

4DIAHD

Diabetes with hypertension and dyslipidemia

Questionnaires+Tongue diagnosis+Pulse diagnosis

Intervention Type: OTHER

Each subject will undergo questionnaires, tongue and pulse diagnosis using modern diagnostic tools

Interventions

Questionnaires+Tongue diagnosis+Pulse diagnosis

Each subject will undergo questionnaires, tongue and pulse diagnosis using modern diagnostic tools

Intervention Type: OTHER

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ministry of Health, Singapore

OTHER_GOV

Sponsor Role: collaborator

Singapore Chung Hwa Medical Institution

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Singapore Chung Hwa Medical Institution

Singapore, , Singapore

Countries

Singapore

References

Ng HP, Chong SY, Li YH, Goh TH, Pang KY, Pereira MJ, Huang CM. Objective Analysis of Traditional Chinese Medicine Syndrome Differentiation of Patients With Diabetes and Prediabetes: Protocol for a Nonrandomized, Exploratory, Observational Case-Control Study Using Digitalized Traditional Chinese Medicine Diagnostic Tools. JMIR Res Protoc. 2024 Sep 12;13:e56024. doi: 10.2196/56024.

Reference Type: DERIVED

PMID: 39265161 (View on PubMed)

Other Identifiers

SCHMI-2022-001

Identifier Type: -

Identifier Source: org_study_id