TCM Syndrome Differentiation of T2DM & MetS

NCT ID: NCT06703684

Last Updated: 2024-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

470 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-20

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Type 2 Metabolic Syndrome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Cross-sectional observational study

This is a cross-sectional observational study. No intervention will be given.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hong Kong Baptist University

OTHER

Sponsor Role lead

Responsible Party

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ZHANG Jialing

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jialing ZHANG, PhD

Role: PRINCIPAL_INVESTIGATOR

Hong Kong Baptist University

Central Contacts

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Jialing ZHANG

Role: CONTACT

Other Identifiers

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REC/23-24/0564

Identifier Type: -

Identifier Source: org_study_id

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