Efficacy of On-venous Laser Irradiation of Blood on Diabetes Kidney Disease Patients

NCT06588465 | Enrolling By Invitation DMC

• 1 other identifier: CMUH113-REC1-062
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The single center, randomized, assessor- and participant-blind, controlled, cross-over on-venous laser irradiation of blood clinical trial was performed to analyze patients with DKD. The information will help to whether integration of laser acupuncture into patient care will help to improve the clinical symptoms and quality of life.

Conditions

Chronic Kidney Diseases; Proteinuria; Diabetes Mellitus

Keywords

Chronic Kidney Diseases; diabetes mellitus

Outcome Measures

Primary Outcomes (3)

• Examine the spot proteinuria changes between the 6th week and at the time of inclusion, as well as between the 13th week and the 6th week.

  A spot urine P/C ratio \>20 mg/mmol (0.2 mg/mg) is the most commonly reported cutoff value for detecting proteinuria

  baseline, 6 weeks, 13weeks

• Examine the eGFR changes between the 6th week and at the time of inclusion, as well as between the 13th week and the 6th week.

  eGFR (estimated glomerular filtration rate) is a measure of how well your kidneys are working. Your eGFR is an estimated number based on a blood test and your age, sex, and body type.

  baseline, 6 weeks, 13weeks

• Examine the albuminuria changes between the 6th week and at the time of inclusion, as well as between the 13th week and the 6th week.

  A ratio of albumin (mcg/L) to creatinine (mg/L) of less than 30 is normal; a ratio of 30-300 signifies microalbuminuria and values above 300 are considered as macroalbuminuria.

  baseline, 6 weeks, 13weeks

Secondary Outcomes (1)

• SF-36

  baseline, 6 weeks, 13weeks, 17 weeks

Other Outcomes (1)

• The constitution in Chinese medicine questionnaire (CCMQ)

  baseline, 6 weeks, 13weeks, 17 weeks

Study Arms (2)

treatment group A

EXPERIMENTAL

We plan to enroll 72 volunteer patients with microalbuminuria. After 1 week waiting period (as the waiting list group), the patients will be randomized to treatment group A or group B.

Device: On-venous Laser Irradiation of Blood; Device: low dose On-venous Laser Irradiation of Blood

treatment group B

EXPERIMENTAL

We plan to enroll 72 volunteer patients with microalbuminuria. After 1 week waiting period (as the waiting list group), the patients will be randomized to treatment group A or group B.

Device: On-venous Laser Irradiation of Blood; Device: low dose On-venous Laser Irradiation of Blood

Interventions

On-venous Laser Irradiation of Blood DEVICE

The treatment will take place three times a week, over six weeks. The On-venous Laser will placed in the body for 60 minutes. A total of 15 laser heads (15 acupoints, bilaterally) will be used in each session.

treatment group A; treatment group B

low dose On-venous Laser Irradiation of Blood DEVICE

The treatment will take place three times a week, over six weeks. The low dose On-venous Laser will placed in the body for 60 minutes. A total of 15 laser heads (15 acupoints, bilaterally) will be used in each session.

treatment group A; treatment group B

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HbA1C≥6.5 % and ≤ 9%, ±0.5% under past three months
• eGFR ≥30ml/min/1.73m2 and protinuria ≥30mg/d under ACEI or ARB treatment

You may not qualify if:

• allergic to laser beans
• Immunosuppressive drugs had been used in the past six months
• urine protein over 3.5 g /day
• Autosomal dominant polycystic kidney disease
• Lupus nephritis
• People with mental illness or other mental disabilities are unable to cooperate with the researcher.
• Those who used non-steroidal analgesics and steroids in the trial period
• Pregnant or lactating women

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, North Dist, 404, Taiwan

Location

Related Publications (2)

• Liu S, Zhang F, Bai Y, Huang L, Zhong Y, Li Y. Therapeutic effects of acupuncture therapy for kidney function and common symptoms in patients with chronic kidney disease: a systematic review and meta-analysis. Ren Fail. 2024 Dec;46(1):2301504. doi: 10.1080/0886022X.2023.2301504. Epub 2024 Jan 8.

  PMID: 38189090 BACKGROUND

• Chuang SM, Lee CC, Lo WY, Hsieh CL. Effect of acupressure at Sanyinjiao on albuminuria in patients with early diabetic nephropathy: A single-blind, randomized, controlled preliminary study. Explore (NY). 2020 May-Jun;16(3):165-169. doi: 10.1016/j.explore.2019.09.001. Epub 2019 Sep 21.

  PMID: 31591045 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Proteinuria; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urological Manifestations; Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• YU-CHEN LEE, Ph.D

  China Medical University, China

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: July 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)