CHM for T2DM & MetS

NCT06450652 | Not Yet Recruiting

• 1 other identifier: REC/23-24/0397
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes Mellitus With Metabolic Syndrome

Outcome Measures

Primary Outcomes (2)

• Fasting plasma glucose (FPG)

  FPG will be determined by taking a blood sample from participants who have fasted for 8-12 hours.

  Baseline, week 2, week 4, week 8.

• Blood pressure

  Blood pressure was measured thrice, after a 10 min rest, using a standard digital sphygmomanometer.

  Baseline, week 2, week 4, week 8.

Secondary Outcomes (6)

• Framingham Stroke Risk Score (FSRS)

  Baseline, week 2, week 4, week 8.

• Audit of diabetes-dependent quality of Life (ADDQoL)

  Baseline, week 4, week 8.

• International Physical Activity Questionnaire Short Form (IPAQ-SF)

  Baseline, week 2, week 4, week 8.

• Anthropometric assessment, lipid panels, HbA1C

  Baseline, week 2, week 4, week 8.

• Physiological parameters and dietary records

  Baseline, week 2, week 4, week 8.

Study Arms (1)

Chinese Herbal Medicine granules

EXPERIMENTAL

Drug: Chinese Herbal Medicine granules

Interventions

Chinese Herbal Medicine granules DRUG

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.

Chinese Herbal Medicine granules

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hong Kong Baptist University: lead

Central Study Contacts

Jialing ZHANG, PhD

CONTACT

(852) 34115024; zhangjialing@hkbu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 10, 2024
• Study Start: June 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: June 10, 2024

Record last verified: 2024-06