Status:
COMPLETED
Enhanced Liver Function in Non-alcoholic Obese Fatty Liver Patients by Low Level Laser Therapy
Lead Sponsor:
Cairo University
Conditions:
Fatty Liver, Nonalcoholic
Liver Function
Eligibility:
All Genders
60-75 years
Phase:
NA
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 prevale...
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....
Eligibility Criteria
Inclusion
- • 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
- • 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
Key Trial Info
Start Date :
January 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04452409
Start Date
January 10 2020
End Date
September 1 2021
Last Update
September 28 2021
Active Locations (1)
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1
Cairo
Giza, Dokki, Egypt, 11432