Enhanced Liver Function in Non-alcoholic Obese Fatty Liver Patients by Low Level Laser Therapy

Study Overview
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Brief Summary
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Non-alcoholic fatty liver disease is excessive fat build-up in the liver with insulin resistance due to causes other than alcohol use.The obesity epidemic is closely associated with the rising prevalence and severity of nonalcoholic fatty liver disease.Currently, the only treatment modality for patients with fatty liver disease is weight loss and exercise which is challenging for most patients. Therefore, a huge need exists for an alternative approach to reducing alanine transaminase (ALT) & aspartate aminotransferase (AST) levels for these patients. Low level laser light therapy (LLLT) offers a simple, non-invasive, safe, effective and side-effect free alternative to achieving this goal, through LLLT's proven ability to effect weight loss, body circumference reduction and lipid profile modification

Detailed Description
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Non-alcoholic fatty liver disease (NAFLD) is a very common disorder and refers to a group of conditions where there is accumulation of excess fat in the liver of people who drink little or no alcohol. The most common form of NAFLD is a non serious condition called fatty liver. NAFLD is part of the metabolic syndrome characterized by diabetes, or pre-diabetes (insulin resistance), being overweight or obese, elevated blood lipids such as cholesterol and triglycerides, as well as high blood pressure. A few studies have suggested that weight loss may be associated with regression of fat within the liver. Therefore, the most important recommendations for people with fatty liver are to lose weight if they are overweight or obese, increase their physical activity, follow a balanced diet and unnecessary medications. Several studies have investigated low-level laser therapy (LLLT) or light-emitting diode (LED) therapy and have made advances in the understanding of the underlying mechanisms LLLT in biological systems. Few studies explain the effect of low level laser therapy on liver enzymes and non alcoholic fatty liver risk factors (as obesity).So, our goal was to perform a randomized controlled trial to investigate the effects of the LLLT on lipid profile, body weight and liver enzymes

Official Title
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Enhanced Liver Function in Non-alcoholic Obese Fatty Liver Patients by Low Level Laser Therapy

Conditions
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Fatty Liver, Nonalcoholic, Liver Function

Intervention / Treatment
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* Device: low level laser
* Other: Mediterranean diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Sixty non-alcoholic fatty liver patients aged from 60-75 y Body mass index (BMI) ranged from 30 to 34.9 kg/m2 Elevated triglyceride & LDL levels Higher Risk Waist Circumference Measurements (Men: 40 or more inches or 102 centimeters or more/ Women: 35 or more inches or 89 centimeters or more) Elevated aminoalanine transaminase (ALT) level, defined as 20 or more Unites/Liter (U/L) above the normal gender-specific ALT levels: males: ALT ≥ 60 U/L; females: ALT ≥ 50 U/L Review of subject's pre-existing medical records to confirm the current diagnosis of nonalcoholic fatty liver according to the following criteria: ALT elevated on two separate determinations Abdominal ultrasound showing fatty liver Blood work that excludes other potential etiologies of liver disease Subject agrees to maintain his or her diet regimen throughout study participation Exclusion Criteria: • History of cardiovascular disease or events including, but not limited to, coronary artery disease, valvular heart disease, cardiac arrhythmias, congestive heart failure, myocardial infarction, stroke, transient ischemic attack, or peripheral vascular disease Cardiac surgeries or procedures, including but not limited to, coronary artery bypass surgery or stent placement, heart transplantation, pacemaker insertion or implantation of a defibrillator An implanted device in the target area to receive low level laser light therapy (e.g. pain pump, lap band, penile inflation device, ventriculo-peritoneal shunts, etc.) Known photosensitivity disorder Current active cancer or within one year of cancer treatment or remission Excessive alcohol consumption defined as 14 or more alcoholic drinks per week Serious mental health illness that in the opinion of the investigator would preclude the subject from study participation Active infection, wound or other external trauma to the target area to receive the laser therapy Developmental disability or cognitive impairment that in the opinion of the investigator would preclude adequate comprehension of the informed consent form and/or ability to record the necessary study measurements Participation in a clinical study or other type of research in the past 30 days

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: study (low level laser plus Mediterranean diet)<br>Active infra -red laser in addition to diet | Device: low level laser<br>* The laser therapy device (660 nm) consisted of abdominal straps containing 4 LED clusters, having 72 LEDs each, applied in the study group paticipants around the patients abdomen and waist after cleaning the target area and wearing safety goggles20, for 30 min., 2 times per week over 12 weeks<br>Other: Mediterranean diet<br>* recommend healthy diet component evaluated periodically by 24 hour recall<br>|
| Other: control (Mediterranean diet only)<br>diet | Other: Mediterranean diet<br>* recommend healthy diet component evaluated periodically by 24 hour recall<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in liver function | measuring liver enzymes (alanine transaminase (ALT) & aspartate aminotransferase (AST) ) and alkaline phosphate before and after low level laser application and the prescribed diet recommendations | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of lipid profile | measuring effect of low level laser application in addition to diet recommendations on lipid profile (low density lipoprotein LDL, high density lipoprotein HDL, total cholesterol T.C and triglyceride T.G) | 3 months | 
| changes of Body Mass Index | measuring effect of low level laser application in addition to diet recommendations on body mass index (weight by Kg / height per meter square) | 3 months | 
| changes of waist circumference | measuring effect of low level laser application in addition to diet recommendations on waist circumference | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low level laser