Clinical trial NCT06450652: CHM for T2DM & MetS
Official title: Feasibility, Safety, and Effectiveness of Chinese Herbal Medicine for T2DM Patients With Comorbid Metabolic Syndrome: A Single-arm Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes Mellitus With Metabolic Syndrome
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 15
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.).
* 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.

Primary outcomes:
measure: Fasting plasma glucose (FPG)
timeFrame: Baseline, week 2, week 4, week 8.
measure: Blood pressure
timeFrame: Baseline, week 2, week 4, week 8.
Secondary outcomes:
measure: Framingham Stroke Risk Score (FSRS)
timeFrame: Baseline, week 2, week 4, week 8.
measure: Audit of diabetes-dependent quality of Life (ADDQoL)
timeFrame: Baseline, week 4, week 8.
measure: International Physical Activity Questionnaire Short Form (IPAQ-SF)
timeFrame: Baseline, week 2, week 4, week 8.
measure: Anthropometric assessment, lipid panels, HbA1C
timeFrame: Baseline, week 2, week 4, week 8.
measure: Physiological parameters and dietary records
timeFrame: Baseline, week 2, week 4, week 8.
measure: Adverse events
timeFrame: Baseline, week 2, week 4, week 8.
Other outcomes:
Locations:
Study officials:
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