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

Primary Purpose

Fatty Liver, Nonalcoholic, Liver Function

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

low level laser

Mediterranean diet

About this trial

This is an interventional supportive care trial for Fatty Liver, Nonalcoholic focused on measuring low level laser

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cairo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

study (low level laser plus Mediterranean diet)

control (Mediterranean diet only)

Arm Description

Active infra -red laser in addition to diet

diet

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

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)

changes of waist circumference

measuring effect of low level laser application in addition to diet recommendations on waist circumference

Full Information

NCT ID

NCT04452409

First Posted

June 25, 2020

Last Updated

September 25, 2021

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT04452409

Brief Title

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

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

January 10, 2020 (Actual)

Primary Completion Date

July 25, 2021 (Actual)

Study Completion Date

September 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fatty Liver, Nonalcoholic, Liver Function

Keywords

low level laser

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

study (low level laser plus Mediterranean diet)

Arm Type

Active Comparator

Arm Description

Active infra -red laser in addition to diet

Arm Title

control (Mediterranean diet only)

Arm Type

Other

Arm Description

diet

Intervention Type

Device

Intervention Name(s)

low level laser

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Mediterranean diet

Intervention Description

recommend healthy diet component evaluated periodically by 24 hour recall

Primary Outcome Measure Information:

Title

changes in liver function

Description

measuring liver enzymes (alanine transaminase (ALT) & aspartate aminotransferase (AST) ) and alkaline phosphate before and after low level laser application and the prescribed diet recommendations

Time Frame

3 months

Secondary Outcome Measure Information:

Title

changes of lipid profile

Description

Time Frame

3 months

Title

changes of Body Mass Index

Description

measuring effect of low level laser application in addition to diet recommendations on body mass index (weight by Kg / height per meter square)

Time Frame

3 months

Title

changes of waist circumference

Description

measuring effect of low level laser application in addition to diet recommendations on waist circumference

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ebtesam Nabil, doctoral

Organizational Affiliation

Cairo University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cairo

City

Giza

State/Province

Dokki

ZIP/Postal Code

11432

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Yes

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

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