Laser Acupuncture in Egyptian Systemic Lupus Females With Insulin Resistance

Study Overview
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Brief Summary
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glucose hemosatasis, oxidative stress, abnormalities of blood pressures, and high inflammatory status is high presented in lupus patients.

Detailed Description
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64 lupus prediabetic women will equally distributed to group A (n =32 that will receive laser acupuncture (active) for one month (3 days week) on acupoint number 14 of GV meridian, acupoint number 4 and 11 of large intestine, acupoint number 34 of gall bladder meridian, acupoint number 3 of liver meridian, acupoint number 4, 12, and 9 of conception vessel meridian, acupoint number 40, 36, and 25 of stomach meridian, acupoint number 6 of spleen meridian, and acupoint number 5 of triple energizer meridian, laser will be applied for 1 min on every acupiont) or group B (n =32 this group will receive the same protocol of group A but the points will be sham points)

Official Title
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Laser Acupuncture in Systemic Lupus Women With Prediabetes

Conditions
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Systemic Lupus Erythematosus, PreDiabetes

Intervention / Treatment
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* Device: active laser
* Device: sham laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: prediabetic lupus females (n =64) Exclusion Criteria: obesity diabetes heart or respiratory problems

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: laser (active laser)<br>32 lupus prediabetic women will receive laser acupuncture (active laser) for one month (3 days week) on acupoint number 14 of GV meridian, acupoint number 4 and 11 of large intestine, acupoint number 34 of gall bladder meridian, acupoint number 3 of liver meridian, acupoint number 4, 12, and 9 of conception vessel meridian, acupoint number 40, 36, and 25 of stomach meridian, acupoint number 6 of spleen meridian, and acupoint number 5 of triple energizer meridian, laser will be applied for 1 min on every acupiont) | Device: active laser<br>* 32 lupus prediabetic women will receive laser acupuncture (active laser) for one month (3 days week) on acupoint number 14 of GV meridian, acupoint number 4 and 11 of large intestine, acupoint number 34 of gall bladder meridian, acupoint number 3 of liver meridian, acupoint number 4, 12, and 9 of conception vessel meridian, acupoint number 40, 36, and 25 of stomach meridian, acupoint number 6 of spleen meridian, and acupoint number 5 of triple energizer meridian, laser will be applied for 1 min on every acupiont)<br>|
| Sham Comparator: laser (sham laser)<br>32 lupus prediabetic women will receive laser acupuncture (sham . i.e power of the device will be zero) for one month (3 days week) on acupoint number 14 of GV meridian, acupoint number 4 and 11 of large intestine, acupoint number 34 of gall bladder meridian, acupoint number 3 of liver meridian, acupoint number 4, 12, and 9 of conception vessel meridian, acupoint number 40, 36, and 25 of stomach meridian, acupoint number 6 of spleen meridian, and acupoint number 5 of triple energizer meridian, laser will be applied for 1 min on every acupiont) | Device: sham laser<br>* 32 lupus prediabetic women will receive laser acupuncture (sham laser, i.e power of device will be zero watt) for one month (3 days week) on acupoint number 14 of GV meridian, acupoint number 4 and 11 of large intestine, acupoint number 34 of gall bladder meridian, acupoint number 3 of liver meridian, acupoint number 4, 12, and 9 of conception vessel meridian, acupoint number 40, 36, and 25 of stomach meridian, acupoint number 6 of spleen meridian, and acupoint number 5 of triple energizer meridian, laser will be applied for 1 min on every acupiont)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Malondialdehyde | oxidative stress indicator | It will be measured after 4 weeks of laser application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| systolic blood pressure | manual sphygmomanometer | It will be measured after 4 weeks of laser application | 
| diastolic blood pressure | manual sphygmomanometer | It will be measured after 4 weeks of laser application | 
| blood glucose | it will be measured in fasting status | It will be measured after 4 weeks of laser application | 
| erythrocyte sedimentation rate (at first hour) | it will be measured in serum | It will be measured after 4 weeks of laser application | 
| erythrocyte sedimentation rate (at second hour) | it will be measured in serum | It will be measured after 4 weeks of laser application | 
| C reactive protein | it will be measured in serum | It will be measured after 4 weeks of laser application | 
| adenosine triphosphate | it a measure for energy production | It will be measured after 4 weeks of laser application | 
| Nitrate | it will be measured in serum | It will be measured after 4 weeks of laser application | 
| Glutathione | it will be measured in serum | It will be measured after 4 weeks of laser application |