Integrated Traditional Chinese Medicine Day Care Program for Metabolic Syndrome

NCT06703788 | Recruiting Phase 1 DMC

• 1 other identifier: MOHW113-CMAP-M-113-000003-B
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to evaluate if a integrated tradtional Chinese medicine (TCM) program for improving metabolic syndrome is applicable. It will also learn about the importance of gut microbiome of subjects with ineffective management. The main questions it aims to answer are: Does a integrated tradtional Chinese medicine (TCM) program could improve metabolic syndrome in six months? Researchers will also explore the determinant factors of successful improvement in metabolic syndrome, including gut microbiome, life style, TCM management compliance. Participants will: Receive integrated TCM program for managing metabolic syndrome. Visit the clinic once every 2-4 weeks for checkups and tests Keep a diary of diet and life style

Conditions

Obesity; Metabolic Syndrome; Dyslipidemias; Diabetes Mellitus

Keywords

obesity; metabolic syndrome; dyslipidemia; diabetes mellitus; integrated traditional Chinese medicine care program

Outcome Measures

Primary Outcomes (1)

• The composite metabolic endpoint

  Body mass index (BMI) decrease one point (or body weight decrease at least 5% from baseline), waist circumstance decrease at least 3%, the glycated haemoglobin decrease at least 10% or lower than 5.7%, blood pressure \<130/80 mmHg, low-density lipoprotein cholesterol \<130 mg/dl and triglyceride \<150mg/dL will be used as composite metabolic outcome. Meet any of the above criteria is considered achieving the treatment goal.

  From date of enrollment until the date of end of study. Follow up parameters every one month, up to six months.

Study Arms (1)

Integrated traditional Chinese medicine care program

EXPERIMENTAL

Integrated traditional Chinese medicine (TCM) care program for metabolic syndrome, including herbal medicine, laser acupuncture, and diet and lifestyle education based on TCM theory.

Drug: A fiixed combination of Chinese herbal medicine; Device: Laser acupuncture

Interventions

A fiixed combination of Chinese herbal medicine DRUG

a fixed combination of Chinese herbal medicine with Ma-Xing-Gang-Shi-Tang (initiate at 2 grams, with increments of 0.5 grams every 2-4 weeks, up to a maximum dose of 4 grams once daily) and Coptis chinensis (initiate at 0.5 grams, with increments of 0.5 grams every 2-4 weeks, up to a maximum dose of 1 gram once daily), twice a day

Integrated traditional Chinese medicine care program

Laser acupuncture DEVICE

Laser acupuncture could be used based on medication therapy at following acupoints: CV9, ST25, SP15, ST28, ST40, and two auricular points (stomach and hunger points)

Integrated traditional Chinese medicine care program

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 20 to 75 years who are eligible for health insurance. (Required)
• Additional Criteria (Any one of the following):
• Central Obesity: Waist circumference ≥90 cm for men or ≥80 cm for women. 2-2. Elevated blood glucose levels (≥100mg/dL or currently on medication control) 2-3. Elevated blood pressure (systolic pressure ≥130mmHg, diastolic pressure ≥85mmHg, or currently on medication control) 2-4. Elevated triglycerides (≥150mg/dL, or currently on medication control).High-Density Lipoprotein Cholesterol (HDL-C) \< 40mg/dL for men or \< 50mg/dL for women, or currently on medication) 2-5. Obesity: BMI ≥ 37.5 or BMI ≥ 32.5 with high-risk complications, such as type 2 diabetes mellitus with glycated hemoglobin levels remaining above 7.5% despite medical treatment, hypertension, sleep apnea syndrome, or fatty liver.

You may not qualify if:

• \. Pregnant or breast-feeding women 2. Endocrine disorders (uncontrolled hypo/hyperthyroidism, adrenal gland disorder) 3. Diagnosis of neurologic or psychiatric diseases 4. Liver or renal dysfunction (AST/ALT higher than 3 times of upper normal limits; eGFR \< 60 mL/min/1.73 m2) 5. Acute stress condition (severe infection, receive major surgery in the recent 1 month) 6. Vision, or hearing impairment 7. With other clinical trial medication 8. With Chinese herbal medicine, acupuncture, electroacupuncture or other traditional Chinese medicine (TCM) managements for obesity or metabolic syndrome in the recent 1 month 9. Heavy smoker, alcoholism or substance abuse 10. Severe organ dysfunction: malignancies, autoimmune diseases

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• Ministry of Health and Welfare, Taiwan: collaborator

Study Sites (1)

Chang Gung Memorial Hospital, Taoyuan and Linkou branches

Taoyuan District, 330, Taiwan

RECRUITING

Related Publications (2)

• Liao YN, Chen HY, Yang CW, Lee PW, Hsu CY, Huang YT, Yang TH. Chinese herbal medicine is associated with higher body weight reduction than liraglutide among the obese population: A real-world comparative cohort study. Front Pharmacol. 2022 Sep 9;13:978814. doi: 10.3389/fphar.2022.978814. eCollection 2022.

  PMID: 36160410 BACKGROUND

• Yu WL, Liao YN, Yang TH, Yang CW, Kao TI, Lee PW, Hsu CY, Huang JL, Huang YT, Chen HY. Laser Acupuncture versus Liraglutide in Treatment of Obesity: A Multi-Institutional Retrospective Cohort Study. Healthcare (Basel). 2024 Jun 26;12(13):1279. doi: 10.3390/healthcare12131279.

  PMID: 38998814 BACKGROUND

MeSH Terms

Conditions

Obesity; Metabolic Syndrome; Dyslipidemias; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Lipid Metabolism Disorders; Endocrine System Diseases

Central Study Contacts

Hsing-Yu Chen, M.D., Ph.D.

CONTACT

886-975366119; b8705016@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Subjects with compatible with diagnosis of metabolic syndrome are the target of this study

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 25, 2024
• Study Start: November 20, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)