- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07543211
Effectiveness of Laser Acupuncture in Improving Arterial Stiffness Among Patients With Cardiorenal Metabolic Syndrome
Background: Cardio-renal metabolic syndrome (CRMS) is a vicious cycle of cardiac, renal, and metabolic disease, representing a high-risk for atherosclerosis. Laser acupuncture modulates vascular inflammation and improves endothelial function via low-level laser therapy (LLLT, <500mW) at acupoints or musculoskeletal pain sites. Few studies have focused on CRMS populations. This study evaluates laser acupuncture effects on arterial stiffness in CRMS.
Purpose: To assess the effects of improvement of laser acupuncture in patients with CRMS, and to evaluate its feasibility as supportive therapy.
Methods: A single-group pre-post design is used. Participants are patients with CRMS receiving laser acupuncture at a Chinese medicine clinic in Taiwan. CRMS is interrelated by cardiac, renal, and metabolic disease. Inclusion criteria require diagnosis in ≥2 of 3 systems (cardiovascular, renal, or metabolic; n = 35). Laser acupuncture will be applied to bilateral BL40 for 12 weeks (1-3 sessions/week, 60mins/session). Pulse wave velocity(PWV) measured by Omron HBP- 8000 as the primary outcome for arterial stiffness. Paired t-tests and GEE will be used for analysis.
Expected Results: PWV is expected to show significant improvement after intervention.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 18 years or older
- Diagnosed with at least two conditions related to cardio-renal-metabolic syndrome (e.g., hypertension, diabetes mellitus, chronic kidney disease, or dyslipidemia)
- Receiving routine laser acupuncture treatment in a clinical setting
- Able to understand the study procedures and provide informed consent
Exclusion Criteria:
- Presence of acute cardiovascular events (e.g., acute myocardial infarction, stroke)
- Acute kidney injury
- Presence of medical devices or conditions that contraindicate the use of laser acupuncture at the treatment site (e.g., arteriovenous shunt)
- Unable to complete the study procedures or follow-up assessments
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in Pulse Wave Velocity (PWV)
Time Frame: Baseline and after 12 weeks of treatment
|
Baseline and after 12 weeks of treatment
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Endocrine System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Chronic Disease
- Disease Attributes
- Metabolic Diseases
- Glucose Metabolism Disorders
- Renal Insufficiency
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Hypertension
- Diabetes Mellitus
- Renal Insufficiency, Chronic
Other Study ID Numbers
- NYCU114227AEF
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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