Chronic Kidney Diseases, Diabetes Mellitus, Proteinuria
Conditions
Keywords
Chronic Kidney Diseases, diabetes mellitus
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.
Interventions
DEVICEOn-venous Laser Irradiation of Blood
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.
DEVICElow dose On-venous Laser Irradiation of Blood
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.
Sponsors
China Medical University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| The constitution in Chinese medicine questionnaire (CCMQ) | baseline, 6 weeks, 13weeks, 17 weeks | The CCMQ contain 60 items that consist of the following nine major constitution types: Gentleness (8 Items), Qi- deficiency (8 Items), Yang-deficiency (7 Items), Yin-deficiency (8 Items), Phlegm-damp (8 Items), Damp-heat (6 Items), Blood-stasis (7 Items), Qi-depression (7 Items), and special diathesis (7 Items) types. |
Countries
Taiwan
Outcome results
None listed