Clinical trial NCT06703684: TCM Syndrome Differentiation of T2DM & MetS
Official title: TCM Syndrome Differentiation of Type 2 Diabetes Comorbid With Metabolic Syndrome
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Diabetes Mellitus, Type 2
Metabolic Syndrome
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
First posted: 2024-11-25
Enrollment: 470
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: TCM syndrome differentiation
timeFrame: Baseline
Secondary outcomes:
measure: Demographic data
timeFrame: Baseline
measure: Anthropometric data
timeFrame: Baseline
measure: Fasting glucose
timeFrame: Baseline
measure: Lipid panel
timeFrame: Baseline
measure: Hemoglobin A1c (HbA1c)
timeFrame: Baseline
measure: Framingham Stroke Risk Score (FSRS)
timeFrame: Baseline
measure: International Physical Activity Questionnaire Short Form (IPAQ-SF)
timeFrame: Baseline
measure: Audit of diabetes-dependent quality of Life (ADDQoL)
timeFrame: Baseline
measure: Pittsburgh sleep quality index (PSQI)
timeFrame: Baseline
measure: Dietary assessment
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: Hong Kong Baptist University
name: Jialing ZHANG, PhD
role: PRINCIPAL_INVESTIGATOR
References: