Type 2 Diabetes Mellitus With Metabolic SyndromeNCT06450652
CHM for T2DM & MetS
A study testing Chinese Herbal Medicine granules in people with Type 2 Diabetes Mellitus With Metabolic Syndrome, run by Hong Kong Baptist University.
Trial summary
This is a single-arm design. A total of 15 Type 2 Diabetes Mellitus (T2DM) patients with comorbid Metabolic Syndrome (MetS) will be recruited from community. The intervention will be a 4-week of Chinese Herbal Medicine granules treatment, which will consist of six Chinese herbs. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus With Metabolic Syndrome
- What is being tested?
- Chinese Herbal Medicine granules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Oct 2024
- Phase
- Interventional
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 30-75y.
- Diagnosed with Type 2 diabetes no more than 5 years.
- Having current prehypertension (systolic blood pressure 130-139 mmHg or diastolic blood pressure 85-89mmHg), or with a history of hypertension (systolic blood pressure 140-159mmHg or diastolic blood pressure 90-99mmHg).
- 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.
- Diagnosed with Accumulation of phlegm and dampness pattern or Intertwined phlegm and blood stasis pattern based on Traditional Chinese Medicine (TCM) theory.
- Stable vital signs and with sufficient sensorimotor and language competency for completing assessments.
Who cannot join
- Allergic history to Chinese herbal drugs or a known allergy to the ingredients of the CHM.
- Diagnosed with type 1 diabetes, steroid-induced diabetes, gestational diabetes, or specific types of diabetes.
- Diabetes accompanied by severe complications such as diabetic nephropathy, diabetic ketoacidosis, etc.
- Secondary obesity (e.g., secondary to pituitary inflammation, tumor, etc.).
- Secondary hypertension (e.g., pheochromocytoma, renal hypertension, etc.).
- Secondary hyperlipidemia (e.g., hypothyroidism, nephrotic syndrome, etc.).
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- Experienced at least one day of diarrhea in the past 7 days.
- With previous stroke history.
- With unconsciousness, aphasia, and cognitive dysfunction.
- With severe heart, liver, or kidney disease or bleeding disorders, or with other serious diseases (e.g. cancer, dementia, etc.).
- Pregnancy or lactation female.
- Had joined other clinical trial within past 4 weeks.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Feasibility, Safety, and Effectiveness of Chinese Herbal Medicine for T2DM Patients With Comorbid Metabolic Syndrome: A Single-arm Pilot Study
This is a single-arm design. A total of 15 Type 2 Diabetes Mellitus (T2DM) patients with comorbid Metabolic Syndrome (MetS) will be recruited from community. The intervention will be a 4-week of Chinese Herbal Medicine granules treatment, which will consist of six Chinese herbs. The primary outcome measure will be fasting plasma glucose and blood pressure. Secondary outcome measures including changes of anthropometric data (body mass index, waist-to-hip ratio), lipid panels (total cholesterol, triglycerides, high-density lipoprotein, low-density lipoprotein), HbA1C, Framingham Stroke Risk Score (FSRS), Audit of diabetes-dependent quality of Life (ADDQoL), International Physical Activity Questionnaire Short Form (IPAQ-SF), daily step count and physiological parameters from wearable watch, dietary record, retinal and sublingual vein imaging, concurrent medications and adverse events.
- Being tested
- Chinese Herbal Medicine granules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese Herbal Medicine granulesDrug
The intervention will be a 4 weeks of Chinese Herbal Medicine (CHM) granules, which will consist of six Chinese herbs. Subjects will take one sachet orally, twice daily after meals for 4 weeks. Way of taking CHM granules is as follow: Add 100ml boiling water into a cup, then pour one pack of granules into the cup and soap it for 2-3 mins. Stir until the granules completely dissolve before drinking.
| Study group | Role | What they receive |
|---|---|---|
| Chinese Herbal Medicine granules | Experimental | Not described Receives: Drug: Chinese Herbal Medicine granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting plasma glucose (FPG)
FPG will be determined by taking a blood sample from participants who have fasted for 8-12 hours.
Measured: Baseline, week 2, week 4, week 8.
Blood pressure
Blood pressure was measured thrice, after a 10 min rest, using a standard digital sphygmomanometer.
Measured: Baseline, week 2, week 4, week 8.
Secondary outcomes (6)
Framingham Stroke Risk Score (FSRS)
The Framingham Stroke Risk Score (FSRS) combines stroke risk factors (sex, age, systolic blood pressure, high-density lipoprotein level, total cholesterol level, smoking, diabetes) to predict 10-year probability of stroke.
Measured: Baseline, week 2, week 4, week 8.
Audit of diabetes-dependent quality of Life (ADDQoL)
The ADDQOL consists of two 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 19 life domains are as follows: leisure activities, working life, local or long-distance journeys, holidays, physical health, family life, friendships and social life, close personal relationships, sex life, physical appearance, self-confidence, motivation to achieve things, people's reactions, feelings about the future, financial situation, living conditions, dependence on others, freedom to eat, and freedom to drink. Lower scores reflect poorer QoL. Finally, a mean weighted impact score (ADDQOL score) is calculated for the entire scale across all applicable domains.
Measured: Baseline, week 4, week 8.
International Physical Activity Questionnaire Short Form (IPAQ-SF)
IPAQ-SF has been recommended as a cost-effective method to assess physical activity. IPAQ-SF records the activity of four intensity levels: 1) vigorous-intensity activity such as aerobics, 2) moderate- intensity activity such as leisure cycling, 3) walking, and 4) sitting. It requires participants to recall the number of days and time spent on different intensity of activities in last 7 day.
Measured: Baseline, week 2, week 4, week 8.
Anthropometric assessment, lipid panels, HbA1C
Anthropometric indices such as body height (BH), body weight (BW), waist circumference (WC) and hip circumference (HC) were measured. Body mass index [(BMI) = BW (kg)/BH (m)2] and waist-to-hip ratio [(WHR) = WC (cm)/HC (cm)] will be calculated. Lipid panels (total cholesterol, triglycerides, high-density lipoprotein, low-density lipoprotein) will be assessed before and after treatment period. Hemoglobin A1c test, as known as HbA1c, measure the amount of blood glucose attached to hemoglobin, indicating the average blood glucose level for the last two to three months. For diabetic patients, an ideal HbA1c level is 48mmol/mol (6.5%) or below.
Measured: Baseline, week 2, week 4, week 8.
Physiological parameters and dietary records
Wearable watch will be used to record patients' daily step count and physiological parameters. Patients' diet will be assessed by 3-day weighed dietary records (two non-consecutive weekdays and one weekend day).
Measured: Baseline, week 2, week 4, week 8.
Adverse events
All adverse events (AEs), defined as any adverse events that occur from the beginning of the participant's enrollment to the end of the trial, regardless of whether there is a causal relationship with the received treatments, that occur in the trial will be recorded.
Measured: Baseline, week 2, week 4, week 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study startJun 2024 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus With Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong Kong Baptist University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZhaoXiang Bian, Hong Kong Baptist University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450652
- Sponsor's protocol ID
- REC/23-24/0397
- Status last verified
- Jun 2024
- First submitted
- 5 Jun 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Safety, and Effectiveness of Chinese Herbal Medicine for T2DM Patients With Comorbid Metabolic Syndrome: A Single-arm Pilot Study
- ClinicalTrials.gov ID
- NCT06450652
- Acronym / sponsor ID
- REC/23-24/0397
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Hong Kong Baptist UniversityUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 10 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-arm design. A total of 15 Type 2 Diabetes Mellitus (T2DM) patients with comorbid Metabolic Syndrome (MetS) will be recruited from community. The intervention will be a 4-week of Chinese Herbal Medicine granules treatment, which will consist of six Chinese herbs. The primary outcome measure will be fasting plasma glucose and blood pressure. Secondary outcome measures including changes of anthropometric data (body mass index, waist-to-hip ratio), lipid panels (total cholesterol, triglycerides, high-density lipoprotein, low-density lipoprotein), HbA1C, Framingham Stroke Risk Score (FSRS), Audit of diabetes-dependent quality of Life (ADDQoL), International Physical Activity Questionnaire Short Form (IPAQ-SF), daily step count and physiological parameters from wearable watch, dietary record, retinal and sublingual vein imaging, concurrent medications and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chinese Herbal Medicine granules | Experimental | Drug: Chinese Herbal Medicine granules |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 30-75y.
- Diagnosed with Type 2 diabetes no more than 5 years.
- Having current prehypertension (systolic blood pressure 130-139 mmHg or diastolic blood pressure 85-89mmHg), or with a history of hypertension (systolic blood pressure 140-159mmHg or diastolic blood pressure 90-99mmHg).
- 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.
- Diagnosed with Accumulation of phlegm and dampness pattern or Intertwined phlegm and blood stasis pattern based on Traditional Chinese Medicine (TCM) theory.
Key exclusion criteria (12 listed)
- Allergic history to Chinese herbal drugs or a known allergy to the ingredients of the CHM.
- Diagnosed with type 1 diabetes, steroid-induced diabetes, gestational diabetes, or specific types of diabetes.
- Diabetes accompanied by severe complications such as diabetic nephropathy, diabetic ketoacidosis, etc.
- Secondary obesity (e.g., secondary to pituitary inflammation, tumor, etc.).
- Secondary hypertension (e.g., pheochromocytoma, renal hypertension, etc.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chinese Herbal Medicine granulesThe intervention will be a 4 weeks of Chinese Herbal Medicine (CHM) granules, which will consist of six Chinese herbs. Subjects will take one sachet orally, twice daily after meals for 4 weeks. Way of taking CHM granules is as follow: Add 100ml boiling water into a cup, then pour one pack of granules into the cup and soap it for 2-3 mins. Stir until the granules completely dissolve before drinking. | Drug | Chinese Herbal Medicine granules |
Primary outcome
Fasting plasma glucose (FPG)
Time frame: Baseline, week 2, week 4, week 8.
FPG will be determined by taking a blood sample from participants who have fasted for 8-12 hours.
Blood pressure
Time frame: Baseline, week 2, week 4, week 8.
Blood pressure was measured thrice, after a 10 min rest, using a standard digital sphygmomanometer.
6 secondary outcomes
Framingham Stroke Risk Score (FSRS)
Time frame: Baseline, week 2, week 4, week 8.
Audit of diabetes-dependent quality of Life (ADDQoL)
Time frame: Baseline, week 4, week 8.
International Physical Activity Questionnaire Short Form (IPAQ-SF)
Time frame: Baseline, week 2, week 4, week 8.
Anthropometric assessment, lipid panels, HbA1C
Time frame: Baseline, week 2, week 4, week 8.
Physiological parameters and dietary records
Time frame: Baseline, week 2, week 4, week 8.
Adverse events
Time frame: Baseline, week 2, week 4, week 8.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Chinese Herbal Medicine granules in people with Type 2 Diabetes Mellitus With Metabolic Syndrome, run by Hong Kong Baptist University.
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 6 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jialing ZHANG, PhD ((852) 34115024, zhangjialing@hkbu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting plasma glucose (FPG) (time frame: Baseline, week 2, week 4, week 8.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2024.