Diabetes Mellitus, Type 2, Metabolic Syndrome
Conditions
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.
Interventions
This is a cross-sectional observational study. No intervention will be given.
Sponsors
Hong Kong Baptist University
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Hong Kong
Contacts
PRINCIPAL_INVESTIGATORJialing ZHANG, PhD
Hong Kong Baptist University
Outcome results
None listed