<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04452409</url>
  </required_header>
  <id_info>
    <org_study_id>P.T.REC/012/002722</org_study_id>
    <nct_id>NCT04452409</nct_id>
  </id_info>
  <brief_title>Enhanced Liver Function in Non-alcoholic Obese Fatty Liver Patients by Low Level Laser Therapy</brief_title>
  <official_title>Enhanced Liver Function in Non-alcoholic Obese Fatty Liver Patients by Low Level Laser Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Non-alcoholic fatty liver disease is excessive fat build-up in the liver with insulin&#xD;
      resistance due to causes other than alcohol use.The obesity epidemic is closely associated&#xD;
      with the rising prevalence and severity of nonalcoholic fatty liver disease.Currently, the&#xD;
      only treatment modality for patients with fatty liver disease is weight loss and exercise&#xD;
      which is challenging for most patients. Therefore, a huge need exists for an alternative&#xD;
      approach to reducing alanine transaminase (ALT) &amp; aspartate aminotransferase (AST) levels for&#xD;
      these patients. Low level laser light therapy (LLLT) offers a simple, non-invasive, safe,&#xD;
      effective and side-effect free alternative to achieving this goal, through LLLT's proven&#xD;
      ability to effect weight loss, body circumference reduction and lipid profile modification&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Non-alcoholic fatty liver disease (NAFLD) is a very common disorder and refers to a group of&#xD;
      conditions where there is accumulation of excess fat in the liver of people who drink little&#xD;
      or no alcohol. The most common form of NAFLD is a non serious condition called fatty liver.&#xD;
&#xD;
      NAFLD is part of the metabolic syndrome characterized by diabetes, or pre-diabetes (insulin&#xD;
      resistance), being overweight or obese, elevated blood lipids such as cholesterol and&#xD;
      triglycerides, as well as high blood pressure. A few studies have suggested that weight loss&#xD;
      may be associated with regression of fat within the liver. Therefore, the most important&#xD;
      recommendations for people with fatty liver are to lose weight if they are overweight or&#xD;
      obese, increase their physical activity, follow a balanced diet and unnecessary medications.&#xD;
&#xD;
      Several studies have investigated low-level laser therapy (LLLT) or light-emitting diode&#xD;
      (LED) therapy and have made advances in the understanding of the underlying mechanisms LLLT&#xD;
      in biological systems. Few studies explain the effect of low level laser therapy on liver&#xD;
      enzymes and non alcoholic fatty liver risk factors (as obesity).So, our goal was to perform a&#xD;
      randomized controlled trial to investigate the effects of the LLLT on lipid profile, body&#xD;
      weight and liver enzymes&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2020</start_date>
  <completion_date type="Actual">September 1, 2021</completion_date>
  <primary_completion_date type="Actual">July 25, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>changes in liver function</measure>
    <time_frame>3 months</time_frame>
    <description>measuring liver enzymes (alanine transaminase (ALT) &amp; aspartate aminotransferase (AST) ) and alkaline phosphate before and after low level laser application and the prescribed diet recommendations</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>changes of lipid profile</measure>
    <time_frame>3 months</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes of Body Mass Index</measure>
    <time_frame>3 months</time_frame>
    <description>measuring effect of low level laser application in addition to diet recommendations on body mass index (weight by Kg / height per meter square)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes of waist circumference</measure>
    <time_frame>3 months</time_frame>
    <description>measuring effect of low level laser application in addition to diet recommendations on waist circumference</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Fatty Liver, Nonalcoholic</condition>
  <condition>Liver Function</condition>
  <arm_group>
    <arm_group_label>study (low level laser plus Mediterranean diet)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Active infra -red laser in addition to diet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control (Mediterranean diet only)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>diet</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>low level laser</intervention_name>
    <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</description>
    <arm_group_label>study (low level laser plus Mediterranean diet)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mediterranean diet</intervention_name>
    <description>recommend healthy diet component evaluated periodically by 24 hour recall</description>
    <arm_group_label>control (Mediterranean diet only)</arm_group_label>
    <arm_group_label>study (low level laser plus Mediterranean diet)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Sixty non-alcoholic fatty liver patients aged from 60-75 y&#xD;
&#xD;
               -  Body mass index (BMI) ranged from 30 to 34.9 kg/m2&#xD;
&#xD;
               -  Elevated triglyceride &amp; LDL levels&#xD;
&#xD;
               -  Higher Risk Waist Circumference Measurements (Men: 40 or more inches or 102&#xD;
                  centimeters or more/ Women: 35 or more inches or 89 centimeters or more)&#xD;
&#xD;
               -  Elevated aminoalanine transaminase (ALT) level, defined as 20 or more&#xD;
                  Unites/Liter (U/L) above the normal gender-specific ALT levels: males: ALT ≥ 60&#xD;
                  U/L; females: ALT ≥ 50 U/L&#xD;
&#xD;
               -  Review of subject's pre-existing medical records to confirm the current diagnosis&#xD;
                  of nonalcoholic fatty liver according to the following criteria:&#xD;
&#xD;
               -  ALT elevated on two separate determinations&#xD;
&#xD;
               -  Abdominal ultrasound showing fatty liver&#xD;
&#xD;
               -  Blood work that excludes other potential etiologies of liver disease&#xD;
&#xD;
               -  Subject agrees to maintain his or her diet regimen throughout study participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • History of cardiovascular disease or events including, but not limited to, coronary&#xD;
             artery disease, valvular heart disease, cardiac arrhythmias, congestive heart failure,&#xD;
             myocardial infarction, stroke, transient ischemic attack, or peripheral vascular&#xD;
             disease&#xD;
&#xD;
               -  Cardiac surgeries or procedures, including but not limited to, coronary artery&#xD;
                  bypass surgery or stent placement, heart transplantation, pacemaker insertion or&#xD;
                  implantation of a defibrillator&#xD;
&#xD;
               -  An implanted device in the target area to receive low level laser light therapy&#xD;
                  (e.g. pain pump, lap band, penile inflation device, ventriculo-peritoneal shunts,&#xD;
                  etc.)&#xD;
&#xD;
               -  Known photosensitivity disorder&#xD;
&#xD;
               -  Current active cancer or within one year of cancer treatment or remission&#xD;
&#xD;
               -  Excessive alcohol consumption defined as 14 or more alcoholic drinks per week&#xD;
&#xD;
               -  Serious mental health illness that in the opinion of the investigator would&#xD;
                  preclude the subject from study participation&#xD;
&#xD;
               -  Active infection, wound or other external trauma to the target area to receive&#xD;
                  the laser therapy&#xD;
&#xD;
               -  Developmental disability or cognitive impairment that in the opinion of the&#xD;
                  investigator would preclude adequate comprehension of the informed consent form&#xD;
                  and/or ability to record the necessary study measurements&#xD;
&#xD;
               -  Participation in a clinical study or other type of research in the past 30 days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ebtesam Nabil, doctoral</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cairo</name>
      <address>
        <city>Giza</city>
        <state>Dokki</state>
        <zip>11432</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>September 25, 2021</last_update_submitted>
  <last_update_submitted_qc>September 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ebtesam Nabil</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <keyword>low level laser</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatty Liver</mesh_term>
    <mesh_term>Non-alcoholic Fatty Liver Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04452409
org study id: P.T.REC/012/002722
nct id: NCT04452409
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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
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
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: changes in liver function
time frame: 3 months
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
measure: changes of lipid profile
time frame: 3 months
description: 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)
measure: changes of Body Mass Index
time frame: 3 months
description: measuring effect of low level laser application in addition to diet recommendations on body mass index (weight by Kg / height per meter square)
measure: changes of waist circumference
time frame: 3 months
description: measuring effect of low level laser application in addition to diet recommendations on waist circumference
arm group label: study (low level laser plus Mediterranean diet)
arm group type: Active Comparator
description: Active infra -red laser in addition to diet
arm group label: control (Mediterranean diet only)
arm group type: Other
description: diet
intervention type: Device
intervention name: low level laser
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
arm group label: study (low level laser plus Mediterranean diet)
intervention type: Other
intervention name: Mediterranean diet
description: recommend healthy diet component evaluated periodically by 24 hour recall
arm group label: control (Mediterranean diet only)
arm group label: study (low level laser plus Mediterranean diet)
criteria: 
gender: All
minimum age: 60 Years
maximum age: 75 Years
healthy volunteers: No
last name: Ebtesam Nabil, doctoral
role: Principal Investigator
affiliation: Cairo University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ebtesam Nabil
investigator title: principal investigator
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease
sharing ipd: Yes
ipd info type: Study Protocol