Clinical trial NCT06588465: Efficacy of On-venous Laser Irradiation of Blood on Diabetes Kidney Disease Patients
Official title: Efficacy of On-venous Laser Irradiation of Blood on Diabetes Kidney Disease Patients: a Single Center, Randomized, Assessor- and Participant-blind, Controlled, Cross-over Clinical Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Chronic Kidney Diseases
Proteinuria
Diabetes Mellitus
Keywords: Chronic Kidney Diseases
diabetes mellitus
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Microalbuminuria is the cardinal symptom of diabetes kidney disease (DKD) and is linked to renal function decline. The cardiovascular risk of patients with DKD is much higher than that of the general population, and cardiovascular diseases is the main cause of death in patients with DKD.

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 on-venous laser irradiation of blood and low dose OLIB group. Each group will include 36 patients and given intervention three times a week. The intervention will then be crossed over to the other one after 1 week of wash-our period. Outcome measurement includes questionnaires, biochemistry analysis, urine routine analysis.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: 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.
timeFrame: baseline, 6 weeks, 13weeks
measure: 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.
timeFrame: baseline, 6 weeks, 13weeks
measure: 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.
timeFrame: baseline, 6 weeks, 13weeks
Secondary outcomes:
measure: SF-36
timeFrame: baseline, 6 weeks, 13weeks, 17 weeks
Other outcomes:
measure: The constitution in Chinese medicine questionnaire (CCMQ)
timeFrame: baseline, 6 weeks, 13weeks, 17 weeks
Locations:
city: Taichung City
country: Taiwan
facility: China Medical University Hospital
state: North Dist
Study officials:
affiliation: China Medical University, China
name: YU-CHEN LEE, Ph.D
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.