<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/NCT04477109</url>
  </required_header>
  <id_info>
    <org_study_id>P.T.REC/012/002677</org_study_id>
    <nct_id>NCT04477109</nct_id>
  </id_info>
  <brief_title>Effectiveness of Low Level Laser Therapy on Insulin Resistance and Inflammatory Biomarkers</brief_title>
  <official_title>Effectiveness of Low Level Laser Therapy on Insulin Resistance and Inflammatory Biomarkers in Obese Postmenopausal Breast Cancer Risk Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      It is an interventional study in which 60 women estimated to enroll according to random&#xD;
      allocation and assigned into two groups equal. The study group will receive active low level&#xD;
      laser in addition to diet recommendations while the control group will stick to the same line&#xD;
      of treatment but with sham laser application. The laser consists of semiconductor and&#xD;
      operates at a wavelength of 650 nanometre. The laser installed in the watch comprises 10&#xD;
      individual laser beams for the wrist and an additional adapter for nasal stimulation. The&#xD;
      output power is 5 megawatt, but it can also be adjusted. The device operates at an ambient&#xD;
      temperature of -20 to +40 ° C and a relative humidity of ≤ 85%. The laser watch can be used&#xD;
      for a variable irradiation period of 10-60 min. the device will be applied on specific&#xD;
      acupuncture points (N acupuncture point, Radial artery acupuncture points, and ulnar artery&#xD;
      acupuncture points) combined with nasal laser irradiation at the same time, once per day, 3&#xD;
      times per week for three months&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PURPOSE:&#xD;
&#xD;
      To determine the effectiveness of low level laser therapy on insulin resistance and&#xD;
      inflammatory biomarkers in obese postmenopausal breast cancer risk women&#xD;
&#xD;
      BACKGROUND:&#xD;
&#xD;
      The American Obesity Association (2002, 2003) defines obesity as 'a complex, multifactorial&#xD;
      chronic disease involving environmental (social and cultural), genetic, physiologic,&#xD;
      metabolic, behavioral, and psychological components'. However, the most commonly used&#xD;
      definitions of obesity are based on BMI, which is defined as weight in kilograms divided by&#xD;
      height in meters squared. In adults, obesity is generally defined as a BMI of 30.0 or&#xD;
      greater. Obesity has become a major contributor to the global burden of chronic disease and&#xD;
      disability. It is a complex condition with serious social and psychological dimensions,&#xD;
      affecting virtually all ages and socioeconomic group Obesity is associated with an increased&#xD;
      risk of developing insulin resistance and type 2 diabetes. In obese individuals, adipose&#xD;
      tissue releases increased amounts of non-esterified fatty acids, glycerol, hormones,&#xD;
      proinflammatory cytokines and other factors that are involved in the development of insulin&#xD;
      resistance. In overweight and obesity, there exists low-grade chronic inflammation&#xD;
      characterized by the increase of cytokines and serum concentrations such as fibrinogen and&#xD;
      C-reactive protein (CRP) The areas of low - intensity laser use have expanded in several&#xD;
      conditions by different mechanisms and ways. LLLT has been used as an important tool for the&#xD;
      control of the inflammatory process. Its anti-inflammatory effect has been studied and its&#xD;
      ability to induce analgesia under different conditions has also been reported. Because laser&#xD;
      acupuncture appears to be safe, it could be considered as a complementary form of palliative&#xD;
      care for prevention of cancer risk, especially for clinical problems for which conventional&#xD;
      care options are limited. Investigations suggest the benefits of low-level laser therapy&#xD;
      (LLLT) to improve noninvasive body contouring treatments, inflammation, insulin resistance&#xD;
      and to reduce body fat.&#xD;
&#xD;
      HYPOTHESES:&#xD;
&#xD;
      Low level laser therapy in form of laser watch has no effect on insulin resistance&#xD;
      inflammatory biomarkers in obese postmenopausal breast cancer risk women&#xD;
&#xD;
      RESEARCH QUESTION:&#xD;
&#xD;
      Does low level laser therapy has an effect on insulin resistance inflammatory biomarkers in&#xD;
      obese postmenopausal breast cancer risk women?&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">April 1, 2023</completion_date>
  <primary_completion_date type="Actual">December 31, 2022</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>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>insulin resistance</measure>
    <time_frame>12 weeks</time_frame>
    <description>change of insulin resistance by Homeostatic Model Assessment of Insulin Resistance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>inflammatory markers</measure>
    <time_frame>12 weeks</time_frame>
    <description>change of inflammatory markers(C-reactive protein-erythrocyte sedimentation rate-White blood cells-lymphocytes)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>body mass index</measure>
    <time_frame>12 weeks</time_frame>
    <description>divide weight by height square</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Insulin Resistance</condition>
  <condition>Inflammatory Markers</condition>
  <arm_group>
    <arm_group_label>low level laser in addition to diet recommendations</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The laser consists of a semiconductor and operates at a wavelength of 650 nanometre. The laser installed in the watch comprises 10 individual laser beams for the wrist and an additional adapter for nasal stimulation. The output power is 5 megawatt, but it can also be adjusted. The device operates at an ambient temperature of -20 to +40 ° C and a relative humidity of ≤ 85%. The laser watch can be used for a variable irradiation period of 10-60 min. the device will be applied on specific acupuncture points (N acupuncture point, Radial artery acupuncture points, and ulnar artery acupuncture points) combined with nasal laser irradiation at the same time, once per day, 3 times per week for three months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sham laser application in addition to diet recommendations</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>while the control group will stick to the same line of treatment but with sham laser application</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>low level laser in addition to diet recommendations</intervention_name>
    <description>The laser consists of a semiconductor and operates at a wavelength of 650 nanometre. The laser installed in the watch comprises 10 individual laser beams for the wrist and an additional adapter for nasal stimulation. The output power is 5 megawatt</description>
    <arm_group_label>low level laser in addition to diet recommendations</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>sham laser application in addition to diet recommendations</intervention_name>
    <description>sham laser application in addition to diet recommendations</description>
    <arm_group_label>sham laser application in addition to diet recommendations</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Sixty Postmenopausal women (60-75 y)&#xD;
&#xD;
               -  Body mass index (BMI) ranged from 30 to 34.9 kg/m2&#xD;
&#xD;
               -  Family history of breast cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • women receiving weight-reduction interventions&#xD;
&#xD;
               -  taking lipid lowering drugs&#xD;
&#xD;
               -  regular medications(e.g., β-blockers, α-blockers, digoxin, diuretics, aspirin,&#xD;
                  nitrates, or hormones)&#xD;
&#xD;
               -  having active chronic illness (e.g., rheumatoid arthritis, hyperthyroidism, and&#xD;
                  inflammatory bowel disease)&#xD;
&#xD;
               -  cognitive impairment that will make it difficult to partake in the study&#xD;
&#xD;
               -  presence of malignant disease&#xD;
&#xD;
               -  blood donation within the last 30 days&#xD;
&#xD;
               -  Participation as a subject in any type of study or research during the prior 90&#xD;
                  days&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>marwa m elsayed, phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>lecturer at physical therapy faculty cairo university</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Physical Therapy</name>
      <address>
        <city>Cairo</city>
        <zip>11432</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>May 7, 2023</last_update_submitted>
  <last_update_submitted_qc>May 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>marwa mahmoud elsayed mahmoud</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin Resistance</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>all IPD that underlie results in a publication</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>one year after completing the study</ipd_time_frame>
    <ipd_access_criteria>journal publishing the study</ipd_access_criteria>
    <ipd_url>http://Scholar.cu.edu.eg/p_t</ipd_url>
  </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/NCT04477109
org study id: P.T.REC/012/002677
nct id: NCT04477109
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
It is an interventional study in which 60 women estimated to enroll according to random
      allocation and assigned into two groups equal. The study group will receive active low level
      laser in addition to diet recommendations while the control group will stick to the same line
      of treatment but with sham laser application. The laser consists of semiconductor and
      operates at a wavelength of 650 nanometre. The laser installed in the watch comprises 10
      individual laser beams for the wrist and an additional adapter for nasal stimulation. The
      output power is 5 megawatt, but it can also be adjusted. The device operates at an ambient
      temperature of -20 to +40 ° C and a relative humidity of ≤ 85%. The laser watch can be used
      for a variable irradiation period of 10-60 min. the device will be applied on specific
      acupuncture points (N acupuncture point, Radial artery acupuncture points, and ulnar artery
      acupuncture points) combined with nasal laser irradiation at the same time, once per day, 3
      times per week for three months
PURPOSE:

      To determine the effectiveness of low level laser therapy on insulin resistance and
      inflammatory biomarkers in obese postmenopausal breast cancer risk women

      BACKGROUND:

      The American Obesity Association (2002, 2003) defines obesity as 'a complex, multifactorial
      chronic disease involving environmental (social and cultural), genetic, physiologic,
      metabolic, behavioral, and psychological components'. However, the most commonly used
      definitions of obesity are based on BMI, which is defined as weight in kilograms divided by
      height in meters squared. In adults, obesity is generally defined as a BMI of 30.0 or
      greater. Obesity has become a major contributor to the global burden of chronic disease and
      disability. It is a complex condition with serious social and psychological dimensions,
      affecting virtually all ages and socioeconomic group Obesity is associated with an increased
      risk of developing insulin resistance and type 2 diabetes. In obese individuals, adipose
      tissue releases increased amounts of non-esterified fatty acids, glycerol, hormones,
      proinflammatory cytokines and other factors that are involved in the development of insulin
      resistance. In overweight and obesity, there exists low-grade chronic inflammation
      characterized by the increase of cytokines and serum concentrations such as fibrinogen and
      C-reactive protein (CRP) The areas of low - intensity laser use have expanded in several
      conditions by different mechanisms and ways. LLLT has been used as an important tool for the
      control of the inflammatory process. Its anti-inflammatory effect has been studied and its
      ability to induce analgesia under different conditions has also been reported. Because laser
      acupuncture appears to be safe, it could be considered as a complementary form of palliative
      care for prevention of cancer risk, especially for clinical problems for which conventional
      care options are limited. Investigations suggest the benefits of low-level laser therapy
      (LLLT) to improve noninvasive body contouring treatments, inflammation, insulin resistance
      and to reduce body fat.

      HYPOTHESES:

      Low level laser therapy in form of laser watch has no effect on insulin resistance
      inflammatory biomarkers in obese postmenopausal breast cancer risk women

      RESEARCH QUESTION:

      Does low level laser therapy has an effect on insulin resistance inflammatory biomarkers in
      obese postmenopausal breast cancer risk women?
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: insulin resistance
time frame: 12 weeks
description: change of insulin resistance by Homeostatic Model Assessment of Insulin Resistance
measure: inflammatory markers
time frame: 12 weeks
description: change of inflammatory markers(C-reactive protein-erythrocyte sedimentation rate-White blood cells-lymphocytes)
measure: body mass index
time frame: 12 weeks
description: divide weight by height square
arm group label: low level laser in addition to diet recommendations
arm group type: Active Comparator
description: The laser consists of a semiconductor and operates at a wavelength of 650 nanometre. The laser installed in the watch comprises 10 individual laser beams for the wrist and an additional adapter for nasal stimulation. The output power is 5 megawatt, but it can also be adjusted. The device operates at an ambient temperature of -20 to +40 ° C and a relative humidity of ≤ 85%. The laser watch can be used for a variable irradiation period of 10-60 min. the device will be applied on specific acupuncture points (N acupuncture point, Radial artery acupuncture points, and ulnar artery acupuncture points) combined with nasal laser irradiation at the same time, once per day, 3 times per week for three months
arm group label: sham laser application in addition to diet recommendations
arm group type: Sham Comparator
description: while the control group will stick to the same line of treatment but with sham laser application
intervention type: Device
intervention name: low level laser in addition to diet recommendations
description: The laser consists of a semiconductor and operates at a wavelength of 650 nanometre. The laser installed in the watch comprises 10 individual laser beams for the wrist and an additional adapter for nasal stimulation. The output power is 5 megawatt
arm group label: low level laser in addition to diet recommendations
intervention type: Other
intervention name: sham laser application in addition to diet recommendations
description: sham laser application in addition to diet recommendations
arm group label: sham laser application in addition to diet recommendations
criteria: 
gender: Female
minimum age: 60 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: marwa m elsayed, phd
role: Principal Investigator
affiliation: lecturer at physical therapy faculty cairo university
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: marwa mahmoud elsayed mahmoud
investigator title: principal investigator
mesh term: Insulin Resistance
sharing ipd: Yes
ipd description: all IPD that underlie results in a publication
ipd info type: Study Protocol
ipd time frame: one year after completing the study
ipd access criteria: journal publishing the study
ipd url: http://Scholar.cu.edu.eg/p_t