TCM Syndrome Differentiation of T2DM & MetS

Hong Kong Baptist University

Status: Not yet enrolling

Conditions: Diabetes Mellitus, Type 2; Metabolic Syndrome

Treatments: Other: Cross-sectional observational study

Study type: Observational

Funder types: Other

Identifiers

NCT06703684

REC/23-24/0564

Details and patient eligibility

About

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.

Full 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.

Enrollment: 470 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.