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
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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.
时间窗: 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.
时间窗: 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.
时间窗: 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.
次要结局
- SF-36(baseline, 6 weeks, 13weeks, 17 weeks)
研究者
Yu-Chen Lee
Attending Physician
China Medical University Hospital