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

Not Applicable

• Conditions: Chronic Kidney Diseases; Proteinuria; Diabetes Mellitus
• Interventions: Device: On-venous Laser Irradiation of Blood; Device: low dose On-venous Laser Irradiation of Blood

• Registration Number: NCT06588465
• Lead Sponsor: China Medical University Hospital

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.

Study Timeline

• Status Verified: 2024-05
• Study Start: 2024-07-01
• Study First Submitted: 2024-09-05
• Study First Submitted QC: 2024-09-06
• Last Update Submitted: 2024-09-06
• Study First Posted: 2024-09-09
• Last Update Posted: 2024-09-09
• Primary Completion: 2024-09-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
treatment group A	On-venous Laser Irradiation of Blood	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.
treatment group A	low dose On-venous Laser Irradiation of Blood	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.
treatment group B	On-venous Laser Irradiation of Blood	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.
treatment group B	low dose On-venous Laser Irradiation of Blood	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.

Primary Outcome Measures

Name	Time	Method
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.	baseline, 6 weeks, 13weeks	A spot urine P/C ratio \>20 mg/mmol (0.2 mg/mg) is the most commonly reported cutoff value for detecting proteinuria
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.	baseline, 6 weeks, 13weeks	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.
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.	baseline, 6 weeks, 13weeks	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.

Secondary Outcome Measures

Name	Time	Method
SF-36	baseline, 6 weeks, 13weeks, 17 weeks	The 36-Item Short Form Survey (SF-36) is outcome measure instrument that is often used, well-researched, self-reported measure of health. It stems from a study called the Medical Outcomes Study for the objective measure of the quality of life.It comprises 36 questions that cover eight domains of health

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung City, North Dist, Taiwan