TCM Syndrome Differentiation of T2DM & MetS

TCM Syndrome Differentiation of Type 2 Diabetes Comorbid With Metabolic Syndrome

This study aims to include type 2 diabetes (T2DM) patients comorbid with metabolic syndrome (MetS). The primary aim of the study is to investigate the TCM (Traditional Chinese Medicine) syndrome differentiation of T2DM comorbid with MetS.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Metabolic Syndrome
• Intervention / Treatment: Other: Cross-sectional observational study

Detailed Description

This study adopts a cross-sectional design, to include type 2 diabetes (T2DM) patients comorbid with metabolic syndrome (MetS). The primary aim of the study is to investigate the TCM (Traditional Chinese Medicine) syndrome differentiation of patients with T2DM and MetS. The demographic data, anthropometric data, fasting glucose and HbA1c, lipid panel, TCM syndrome differentiation information, dietary assessment, physical activity, sleep quality, and quality of life, will be assessed.

• Study Type: Observational
• Enrollment (Actual): 470

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Hong Kong Baptist University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

This study adopts a cross-sectional design, to include subjects with type 2 diabetes (T2DM) patients comorbid with metabolic syndrome (MetS), irrespective of T2DM duration.

Description

Inclusion Criteria:

• (1) Age between 18-75y.
• (2) Diagnosed with Type 2 diabetes.
• (3) Diagnosed with Metabolic Syndrome according to Guideline for the prevention and treatment of type 2 diabetes mellitus in China (2020 edition) from Chinese Diabetes Society. People who meet 3 of the following diagnostic criteria or more can be diagnosed as Metabolic Syndrome: (a) Abdominal obesity: waist circumference ≥ 90cm for male and ≥ 85cm for female; (b) Hyperglycemia: Fasting blood glucose ≥ 6.1mmol/L or 2-hour postprandial glucose ≥ 7.8mmol/L and/or those who have been diagnosed with hyperglycemia and in treatment; (c) Hypertension: blood pressure ≥ 130/85mmHg and/or those who have been diagnosed with hypertension and in treatment; (d) Fasting triglyceride ≥ 1.70mmol/L; (e) Fasting HDL-C < 1.04mmol/L.
• (4) Clearly understand the content of the study and voluntarily sign the informed consent form.
• (5) Provide complete data (basic information, TCM diagnosis data, and blood test results).

Exclusion Criteria:

• (1) Diagnosed with type 1 diabetes, steroid-induced diabetes, gestational diabetes, or specific types of diabetes.
• (2) Diabetes accompanied by severe complications such as diabetic nephropathy, diabetic ketoacidosis, etc.
• (3) Secondary obesity (e.g., secondary to pituitary inflammation, tumor, etc.).
• (4) Secondary hypertension (e.g., pheochromocytoma, renal hypertension, etc.).
• (5) Secondary hyperlipidemia (e.g., hypothyroidism, nephrotic syndrome, etc.).
• (6) With severe heart, liver, or kidney disease or bleeding disorders, or with other serious diseases (e.g. cancer, dementia, etc.).
• (7) With severe mental disorders, speech or hearing impairments.
• (8) Pregnancy or lactation female.
• (9) Currently join other clinical trial.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TCM syndrome differentiation	A registered Chinese medicine practitioner (CMP) will conduct the TCM syndrome differentiation assessment using a standardized questionnaire, incorporating four TCM diagnostic methods.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic data	Gender, date of birth, living status, marital status, education level, income status, occupation, work status, smoking history, alcohol consumption history, allergy history, medical history, etc.	Baseline
Anthropometric data	Anthropometric measurements such as skin fold thickness measurements.	Baseline
Fasting glucose	Fasting glucose level is measured.	Baseline
Lipid panel	Total cholesterol, triglycerides, high-density lipoprotein, low-density lipoprotein levels are measured.	Baseline
Hemoglobin A1c (HbA1c)	HbA1C level is measured.	Baseline
Framingham Stroke Risk Score (FSRS)	Framingham Stroke Risk Score (FSRS) is calculated based on variables such as age, cholesterol, blood pressure, diabetes, and smoking. Individuals with low risk have 10% or less risk at 10 years, with intermediate risk 10-20%, and with high risk 20% or more.	Baseline
International Physical Activity Questionnaire Short Form (IPAQ-SF)	International Physical Activity Questionnaire Short Form (IPAQ-SF) has been recommended as a cost-effective method to assess physical activity. The IPAQ-SF evaluates the number of days and time spent performing MVPA, walking, and sitting in bouts of at least 10 min over the previous 7 days. The summary score is expressed in PA metabolic equivalent of task (MET)-min per day or week.	Baseline
Audit of diabetes-dependent quality of Life (ADDQoL)	Audit of diabetes-dependent quality of Life (ADDQoL) consists of 2 overview items; one measures generic overall QoL and a further 19 items are concerned with the impact of diabetes on specific aspects of life. The scales range from -3 to +1 for 19 life domains (impact rating) and from 0 to +3 in attributed importance (importance rating). A weighted score for each domain is calculated as a multiplier of impact rating and importance rating (ranging from -9 to +3). Lower scores reflect poorer QOL.	Baseline
Pittsburgh sleep quality index (PSQI)	Pittsburgh sleep quality index (PSQI) was a 19-item questionnaire used to assess sleep dysfunction over a 1-month period. The total score for the PSQI varies from 0 to 21. A PSQI total score >5 is indicative of poor sleep.	Baseline
Dietary assessment	Dietary intake will be assessed via food frequency questionnaire (FFQ). The 60-item FFQ (<30 min for administration) with food items will be used.	Baseline

Collaborators and Investigators

• Sponsor: Hong Kong Baptist University
• Investigators: Principal Investigator: Jialing ZHANG, PhD, Hong Kong Baptist University

Publications and helpful links

General Publications

• Zhang J, Wong HK, Lin Z, Zhong S, Ma M, Wang X. Traditional Chinese Medicine Syndrome Differentiation of Adult Patients With Type 2 Diabetes and Metabolic Syndrome: Protocol for a Cross-Sectional Study. JMIR Res Protoc. 2026 Jan 23;15:e86217. doi: 10.2196/86217.

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2024
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: November 17, 2024
• First Submitted That Met QC Criteria: November 22, 2024
• First Posted (Actual): November 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Insulin Resistance; Hyperinsulinism; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Metabolic Syndrome
• Other Study ID Numbers: REC/23-24/0564

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No