Clinical trial NCT04452409: Enhanced Liver Function in Non-alcoholic Obese Fatty Liver Patients by Low Level Laser Therapy
Official title: Enhanced Liver Function in Non-alcoholic Obese Fatty Liver Patients by Low Level Laser Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatty Liver, Nonalcoholic
Liver Function
Keywords: low level laser
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-06-30
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: changes in liver function
timeFrame: 3 months
Secondary outcomes:
measure: changes of lipid profile
timeFrame: 3 months
measure: changes of Body Mass Index
timeFrame: 3 months
measure: changes of waist circumference
timeFrame: 3 months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo
state: Dokki
Study officials:
affiliation: Cairo University
name: Ebtesam Nabil, doctoral
role: PRINCIPAL_INVESTIGATOR
References: