TCM Syndrome Differentiation of Type 2 Diabetes Comorbid With Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 470
- 主要终点
- TCM syndrome differentiation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(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).
排除标准
- •(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.
结局指标
主要结局
TCM syndrome differentiation
时间窗: Baseline
A registered Chinese medicine practitioner (CMP) will conduct the TCM syndrome differentiation assessment using a standardized questionnaire, incorporating four TCM diagnostic methods.
次要结局
- Lipid panel(Baseline)
- Demographic data(Baseline)
- Anthropometric data(Baseline)
- Fasting glucose(Baseline)
- Hemoglobin A1c (HbA1c)(Baseline)
- Framingham Stroke Risk Score (FSRS)(Baseline)
- International Physical Activity Questionnaire Short Form (IPAQ-SF)(Baseline)
- Audit of diabetes-dependent quality of Life (ADDQoL)(Baseline)
- Pittsburgh sleep quality index (PSQI)(Baseline)
- Dietary assessment(Baseline)
研究者
ZHANG Jialing
Principal Investigator
Hong Kong Baptist University