NCT07543211

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
5mo left

Started May 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
May 2026Oct 2026

First Submitted

Initial submission to the registry

April 15, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 21, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

April 15, 2026

Last Update Submit

April 15, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Pulse Wave Velocity (PWV)

    Baseline and after 12 weeks of treatment

Interventions

Low-level laser therapy applied to acupuncture points as part of routine clinical treatment. No additional intervention is assigned for research purposes.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants are adult patients diagnosed with cardio-renal-metabolic syndrome who are receiving routine laser acupuncture treatment in a clinical setting. The study population includes individuals with conditions such as hypertension, diabetes mellitus, chronic kidney disease, or dyslipidemia.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HypertensionDiabetes MellitusRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 15, 2026

First Posted

April 21, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

April 21, 2026

Record last verified: 2026-04