TCM Syndrome Differentiation of T2DM & MetS

Not yet recruiting

• Conditions: Diabetes Mellitus, Type 2; Metabolic Syndrome

• Registration Number: NCT06703684
• Lead Sponsor: Hong Kong Baptist University

Brief Summary

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.

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 Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-17
• Study Start: 2024-11-20
• Study First Submitted QC: 2024-11-22
• Last Update Submitted: 2024-11-22
• Study First Posted: 2024-11-25
• Last Update Posted: 2024-11-25
• Primary Completion: 2025-11-19
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 470

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Demographic data	Baseline	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.
Anthropometric data	Baseline	Anthropometric measurements such as skin fold thickness measurements.
Fasting glucose	Baseline	Fasting glucose level is measured.
Lipid panel	Baseline	Total cholesterol, triglycerides, high-density lipoprotein, low-density lipoprotein levels are measured.
Hemoglobin A1c (HbA1c)	Baseline	HbA1C level is measured.
Framingham Stroke Risk Score (FSRS)	Baseline	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.
International Physical Activity Questionnaire Short Form (IPAQ-SF)	Baseline	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.
Audit of diabetes-dependent quality of Life (ADDQoL)	Baseline	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.
Pittsburgh sleep quality index (PSQI)	Baseline	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.
Dietary assessment	Baseline	Dietary intake will be assessed via food frequency questionnaire (FFQ). The 60-item FFQ (\<30 min for administration) with food items will be used.