NCT06703684

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
470

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

November 20, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 25, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

1.1 years

First QC Date

November 17, 2024

Last Update Submit

March 26, 2026

Conditions

Diabetes Mellitus, Type 2Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • TCM syndrome differentiation

    A registered Chinese medicine practitioner (CMP) will conduct the TCM syndrome differentiation assessment using a standardized questionnaire, incorporating four TCM diagnostic methods.

    Baseline

Secondary Outcomes (10)

  • Demographic data

    Baseline

  • Anthropometric data

    Baseline

  • Fasting glucose

    Baseline

  • Lipid panel

    Baseline

  • Hemoglobin A1c (HbA1c)

    Baseline

  • +5 more secondary outcomes

Interventions

Cross-sectional observational studyOTHER

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

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • (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).

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hong Kong Baptist University

Hong Kong, Hong Kong

Location

Related Publications (1)

  • Zhang J, Wong HK, Lin Z, Zhong S, Ma M, Wang X. Traditional Chinese Medicine Syndrome Differentiation of Adult Patients With Type 2 Diabetes and Metabolic Syndrome: Protocol for a Cross-Sectional Study. JMIR Res Protoc. 2026 Jan 23;15:e86217. doi: 10.2196/86217.

    PMID: 41576380DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Metabolic Syndrome

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesInsulin ResistanceHyperinsulinism

Study Officials

  • Jialing ZHANG, PhD

    Hong Kong Baptist University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 17, 2024

First Posted

November 25, 2024

Study Start

November 20, 2024

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

March 31, 2026

Record last verified: 2026-03

Locations

HK(1)