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

NCT04452409 | Completed DMC

• 1 other identifier: P.T.REC/012/002722
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Fatty Liver, Nonalcoholic; Liver Function

Keywords

low level laser

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• changes of lipid profile

  3 months

• changes of Body Mass Index

  3 months

• changes of waist circumference

  3 months

Study Arms (2)

study (low level laser plus Mediterranean diet)

ACTIVE COMPARATOR

Active infra -red laser in addition to diet

Device: low level laser; Other: Mediterranean diet

control (Mediterranean diet only)

OTHER

diet

Other: Mediterranean diet

Interventions

low level laser DEVICE

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

study (low level laser plus Mediterranean diet)

Mediterranean diet OTHER

recommend healthy diet component evaluated periodically by 24 hour recall

control (Mediterranean diet only); study (low level laser plus Mediterranean diet)

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo

Giza, Dokki, 11432, Egypt

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Low-Level Light Therapy; Diet, Mediterranean

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy; Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Ebtesam Nabil, doctoral

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: June 25, 2020
• First Posted: June 30, 2020
• Study Start: January 10, 2020
• Primary Completion: July 25, 2021
• Study Completion: September 1, 2021
• Last Updated: September 28, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)