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Diabetes Mellitus, Type 2NCT06703684

TCM Syndrome Differentiation of T2DM & MetS

An observational study of Diabetes Mellitus, Type 2 and Metabolic Syndrome, run by Hong Kong Baptist University at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetes Mellitus, Type 2, Metabolic Syndrome
What is being tested?
Cross-sectional observational study
How many people
470 participants
Where
1 siteHong Kong
Study dates
20 Nov 2024to 31 Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • (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).

Who cannot join

  • (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.).
Show all 9Show fewer
  • (7) With severe mental disorders, speech or hearing impairments.
  • (8) Pregnancy or lactation female.
  • (9) Currently join other clinical trial.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • Hong Kong Baptist University

    Hong Kong

Other trials in Hong Kong

About this study

Official title: TCM Syndrome Differentiation of Type 2 Diabetes Comorbid With Metabolic Syndrome

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.

Read the 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.

Being tested
Cross-sectional observational study
Medical subject headings
Diabetes Mellitus, Type 2, Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cross-sectional observational studyOther

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline

Secondary outcomes (10)

  1. Demographic data

    Gender, date of birth, living status, marital status, education level, income status, occupation, work status, smoking history, alcohol consumption history, allergy history, medical history, etc.

    Measured: Baseline

  2. Anthropometric data

    Anthropometric measurements such as skin fold thickness measurements.

    Measured: Baseline

  3. Fasting glucose

    Fasting glucose level is measured.

    Measured: Baseline

  4. Lipid panel

    Total cholesterol, triglycerides, high-density lipoprotein, low-density lipoprotein levels are measured.

    Measured: Baseline

  5. Hemoglobin A1c (HbA1c)

    HbA1C level is measured.

    Measured: Baseline

  6. Framingham Stroke Risk Score (FSRS)

    Framingham Stroke Risk Score (FSRS) is calculated based on variables such as age, cholesterol, blood pressure, diabetes, and smoking. Individuals with low risk have 10% or less risk at 10 years, with intermediate risk 10-20%, and with high risk 20% or more.

    Measured: Baseline

  7. International Physical Activity Questionnaire Short Form (IPAQ-SF)

    International Physical Activity Questionnaire Short Form (IPAQ-SF) has been recommended as a cost-effective method to assess physical activity. The IPAQ-SF evaluates the number of days and time spent performing MVPA, walking, and sitting in bouts of at least 10 min over the previous 7 days. The summary score is expressed in PA metabolic equivalent of task (MET)-min per day or week.

    Measured: Baseline

  8. Audit of diabetes-dependent quality of Life (ADDQoL)

    Audit of diabetes-dependent quality of Life (ADDQoL) consists of 2 overview items; one measures generic overall QoL and a further 19 items are concerned with the impact of diabetes on specific aspects of life. The scales range from -3 to +1 for 19 life domains (impact rating) and from 0 to +3 in attributed importance (importance rating). A weighted score for each domain is calculated as a multiplier of impact rating and importance rating (ranging from -9 to +3). Lower scores reflect poorer QOL.

    Measured: Baseline

  9. Pittsburgh sleep quality index (PSQI)

    Pittsburgh sleep quality index (PSQI) was a 19-item questionnaire used to assess sleep dysfunction over a 1-month period. The total score for the PSQI varies from 0 to 21. A PSQI total score >5 is indicative of poor sleep.

    Measured: Baseline

  10. Dietary assessment

    Dietary intake will be assessed via food frequency questionnaire (FFQ). The 60-item FFQ (<30 min for administration) with food items will be used.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2024
  2. Study start20 Nov 2024
  3. Primary completion31 Dec 2025
  4. Study completion31 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
470 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06703684
Sponsor's protocol ID
REC/23-24/0564
Status last verified
Mar 2026
First submitted
17 Nov 2024
Last updated
31 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Zhang J, Lin Z, Zhong S, Ma M, Wong HK, Li LS, Lo KKH, Bian Z. Traditional Chinese medicine syndrome patterns and associated factors in adults with type 2 diabetes and metabolic syndrome: a data-driven analysis. Front Endocrinol (Lausanne). 2026 Jun 17;17:1843491. doi: 10.3389/fendo.2026.1843491. eCollection 2026.

    PubMed 42388871

  • 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.

    PubMed 41576380

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 2 and Metabolic Syndrome, run by Hong Kong Baptist University at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

TCM syndrome differentiation (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06703684, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.

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