xml: <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/NCT06017726</url>
    </required_header>
    <id_info>
      <org_study_id>IR in Egyptian MS patients</org_study_id>
      <nct_id>NCT06017726</nct_id>
    </id_info>
    <brief_title>Insulin Resistance in Egyptian Patients With Multiple Sclerosis</brief_title>
    <acronym>IR-MS</acronym>
    <official_title>Insulin Resistance in Non-diabetic Multiple Sclerosis Patients: Prevalence, Pre and Post-treatment Effect on Clinical, Cognitive Profile, Laboratory, and Radiological Markers</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut University</source>
    <oversight_info>
      <has_dmc>No</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>
        The goal of this three-phase interventional study is to determine the prevalence of Insulin&#xD;
        resistance in non-diabetic patients with multiple sclerosis in Egypt&#xD;
  &#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
          1. what is the prevalence of insult resistance among Egyptian patients with Multiple&#xD;
             sclerosis?&#xD;
  &#xD;
          2. what are the effects of insulin resistance on multiple sclerosis disease activity and&#xD;
             progression&#xD;
  &#xD;
          3. what are the effects of treating insulin resistance on multiple sclerosis disease&#xD;
             activity and progression participants with MS will be tested for IR to determine its&#xD;
             prevalence, in the 2nd phase a group of MS patients with IR will be compared with&#xD;
             another control group of MS patients without IR for clinical, laboratory, and&#xD;
             radiological markers of disease activity and progression twice at baseline and after 1&#xD;
             year. in the 3rd phase, patients with IR will be divided into 2 groups one who will&#xD;
             receive appropriate treatment for IR and the other group without treatment of IR and&#xD;
             will be compared by the end of the 2nd year for clinical, laboratory and radiological&#xD;
             markers of disease activity and progression&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this longitudinal, three-phase, case-control, interventional study, with 250 patients with&#xD;
        multiple sclerosis diagnosed according to the 2017 McDonald's criteria will be enrolled.&#xD;
        Frist diagnosis of cases of insulin resistant MS patient out of the total sample of MS&#xD;
        through estimation of fasting blood glucose, insulin level, and homeostatic model assessment&#xD;
        of insulin resistance (HOMA-IR) index. Other supportive indices like waste circumference,&#xD;
        hemoglobin A1c, and lipid profile will be used. At the end of first phase, prevalence of IR&#xD;
        and associated metabolic syndrome will be determined. In the second phase of the study,&#xD;
        patients will be divided into two groups with and without IR. Cognitive status will be&#xD;
        evaluated with BICAMS test. Physical disability will be evaluated by the EDSS score, 9-hole&#xD;
        pig and 25-foot-walk test. Patients will be assessed for other comorbid conditions like&#xD;
        fatigue and depression. Serum light chain neurofilaments as a laboratory marker for axonal&#xD;
        degeneration will be used. Diffusion tensor imaging with a fully automated too (volbrain)&#xD;
        will be used. Patients in the second phase of the study will be evaluated both at baseline&#xD;
        and after one year. In the third phase, patients with IR will be divided randomly into two&#xD;
        equal groups (1:1) using closed envelope: intervention group who will receive appropriate&#xD;
        treatment for IR and a control group with placebo treatment (without IR treatment) and by the&#xD;
        end of the second year all groups will be evaluated blindly using the same evaluating&#xD;
        measures (clinical, laboratory and radiological)&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 2024</start_date>
    <completion_date type="Anticipated">June 2027</completion_date>
    <primary_completion_date type="Anticipated">December 2026</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>prevalence of insulin resistance among Egyptians with multiple sclerosis</measure>
      <time_frame>this will be determined in the first 2 months of the study (phase 1 of the study)</time_frame>
      <description>to determine the prevalence of Insulin resistance among Egyptian patients with multiple sclerosis using the homeostatic model assessment of insulin resistance (HOMA-IR) index</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>effect of insulin resistance on Multiple sclerosis disease activity</measure>
      <time_frame>this evaluation will be done at 2 points; at the beginning and the end of the first year of the study (phase 2)</time_frame>
      <description>disease activity (indicated by either annualized relapse rate or radiological activity) will be compared between MS patients with and without Insulin resistance</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>effect of insulin resistance on Multiple sclerosis disease progression</measure>
      <time_frame>this evaluation will be done at 2 points; at the beginning and the end of the first year of the study (phase 2)</time_frame>
      <description>disease progression (indicated by either changes in BICAMS scores, or radiological markers of progression) will be compared between MS patients with and without Insulin resistance</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>effect of treating insulin resistance on Multiple sclerosis disease activity</measure>
      <time_frame>this evaluation will be done at 2 points; at the beginning and the end of the second year of the study (phase 3)</time_frame>
      <description>disease activity (indicated by either annualized relapse rate or radiological activity) will be compared between MS patients with treated and untreated Insulin resistance</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>effect of treating insulin resistance on Multiple sclerosis disease progression</measure>
      <time_frame>this evaluation will be done at 2 points; at the beginning and the end of the second year of the study (phase 3)</time_frame>
      <description>disease progression (indicated by either changes in BICAMS scores or radiological markers of progression) will be compared between MS patients with treated and untreated Insulin resistance</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Multiple Sclerosis</condition>
    <condition>Insulin Resistance</condition>
    <arm_group>
      <arm_group_label>Multiple sclerosis patients without insulin resistance</arm_group_label>
      <description>Cognitive status will be evaluated with BICAMS test. Physical disability will be evaluated by the EDSS score, 9-hole pig and 25-foot-walk test. Patients will be assessed for other comorbid conditions like fatigue and depression. Serum light chain neurofilaments as a laboratory marker for axonal degeneration will be used. brain imaging will be done with with Diffusion tensor imaging.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Multiple sclerosis patients with treated insulin resistance</arm_group_label>
      <description>before and after treatment of insulin resistance Cognitive status will be evaluated with BICAMS test. Physical disability will be evaluated by the EDSS score, 9-hole pig and 25-foot-walk test. Patients will be assessed for other comorbid conditions like fatigue and depression. Serum light chain neurofilaments as a laboratory marker for axonal degeneration will be used. brain imaging will be done with with Diffusion tensor imaging.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Multiple sclerosis patients with untreated insulin resistance</arm_group_label>
      <description>at the end of the 1st and 2nd year of the study, Cognitive status will be evaluated with BICAMS test. Physical disability will be evaluated by the EDSS score, 9-hole pig and 25-foot-walk test. Patients will be assessed for other comorbid conditions like fatigue and depression. Serum light chain neurofilaments as a laboratory marker for axonal degeneration will be used. brain imaging will be done with with Diffusion tensor imaging.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>treatment of insulin resistance with appropriate modality according to each patient</intervention_name>
      <description>insulin resistance will be treated with either diet alone or combined diet and appropriate pharmacological treatment with the net result of normalization of HOMA IR index</description>
      <arm_group_label>Multiple sclerosis patients with treated insulin resistance</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          multiple sclerosis patients diagnosed according to the revised McDonald's Criteria for&#xD;
          diagnosis of multiple sclerosis 2017 of different phenotypes (relapsing-remitting, primary&#xD;
          progressive, and secondary progressive)&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  seventy patients aged 18-50 years old of both sex fulfilling the revised McDonald's&#xD;
               Criteria for diagnosis of multiple sclerosis 2017 of different phenotypes&#xD;
               (relapsing-remitting, primary progressive, and secondary progressive), will be&#xD;
               recruited during their follow-up visits to our MS unit.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  • Recent MS relapse or use of corticosteroids in the past 3 months&#xD;
  &#xD;
                 -  patients with a systemic disease like diabetes mellitus, hypertension, cardiac&#xD;
                    disease, liver or renal disease or alcoholic patients&#xD;
  &#xD;
                 -  patients who are on a specific diet.&#xD;
  &#xD;
                 -  patients using any anti-inflammatory drugs, cholesterol-lowering agents, estrogen&#xD;
                    replacement therapy, steroid therapy or other drugs that could affect the&#xD;
                    metabolic profile.&#xD;
  &#xD;
                 -  Patients with non-MS demyelinating disorders like NMOSD and MOGAD.&#xD;
  &#xD;
                 -  Patients who failed to commit to regular follow-ups.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>doaa mokhtar mahmoud</investigator_full_name>
      <investigator_title>lecturer</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Multiple Sclerosis</mesh_term>
      <mesh_term>Insulin Resistance</mesh_term>
      <mesh_term>Sclerosis</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Insulin</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06017726
  org study id: IR in Egyptian MS patients
  nct id: NCT06017726
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this three-phase interventional study is to determine the prevalence of Insulin
        resistance in non-diabetic patients with multiple sclerosis in Egypt
  
        The main questions it aims to answer are:
  
          1. what is the prevalence of insult resistance among Egyptian patients with Multiple
             sclerosis?
  
          2. what are the effects of insulin resistance on multiple sclerosis disease activity and
             progression
  
          3. what are the effects of treating insulin resistance on multiple sclerosis disease
             activity and progression participants with MS will be tested for IR to determine its
             prevalence, in the 2nd phase a group of MS patients with IR will be compared with
             another control group of MS patients without IR for clinical, laboratory, and
             radiological markers of disease activity and progression twice at baseline and after 1
             year. in the 3rd phase, patients with IR will be divided into 2 groups one who will
             receive appropriate treatment for IR and the other group without treatment of IR and
             will be compared by the end of the 2nd year for clinical, laboratory and radiological
             markers of disease activity and progression
  In this longitudinal, three-phase, case-control, interventional study, with 250 patients with
        multiple sclerosis diagnosed according to the 2017 McDonald's criteria will be enrolled.
        Frist diagnosis of cases of insulin resistant MS patient out of the total sample of MS
        through estimation of fasting blood glucose, insulin level, and homeostatic model assessment
        of insulin resistance (HOMA-IR) index. Other supportive indices like waste circumference,
        hemoglobin A1c, and lipid profile will be used. At the end of first phase, prevalence of IR
        and associated metabolic syndrome will be determined. In the second phase of the study,
        patients will be divided into two groups with and without IR. Cognitive status will be
        evaluated with BICAMS test. Physical disability will be evaluated by the EDSS score, 9-hole
        pig and 25-foot-walk test. Patients will be assessed for other comorbid conditions like
        fatigue and depression. Serum light chain neurofilaments as a laboratory marker for axonal
        degeneration will be used. Diffusion tensor imaging with a fully automated too (volbrain)
        will be used. Patients in the second phase of the study will be evaluated both at baseline
        and after one year. In the third phase, patients with IR will be divided randomly into two
        equal groups (1:1) using closed envelope: intervention group who will receive appropriate
        treatment for IR and a control group with placebo treatment (without IR treatment) and by the
        end of the second year all groups will be evaluated blindly using the same evaluating
        measures (clinical, laboratory and radiological)
  observational model: Case-Control
  time perspective: Prospective
  measure: prevalence of insulin resistance among Egyptians with multiple sclerosis
  time frame: this will be determined in the first 2 months of the study (phase 1 of the study)
  description: to determine the prevalence of Insulin resistance among Egyptian patients with multiple sclerosis using the homeostatic model assessment of insulin resistance (HOMA-IR) index
  measure: effect of insulin resistance on Multiple sclerosis disease activity
  time frame: this evaluation will be done at 2 points; at the beginning and the end of the first year of the study (phase 2)
  description: disease activity (indicated by either annualized relapse rate or radiological activity) will be compared between MS patients with and without Insulin resistance
  measure: effect of insulin resistance on Multiple sclerosis disease progression
  time frame: this evaluation will be done at 2 points; at the beginning and the end of the first year of the study (phase 2)
  description: disease progression (indicated by either changes in BICAMS scores, or radiological markers of progression) will be compared between MS patients with and without Insulin resistance
  measure: effect of treating insulin resistance on Multiple sclerosis disease activity
  time frame: this evaluation will be done at 2 points; at the beginning and the end of the second year of the study (phase 3)
  description: disease activity (indicated by either annualized relapse rate or radiological activity) will be compared between MS patients with treated and untreated Insulin resistance
  measure: effect of treating insulin resistance on Multiple sclerosis disease progression
  time frame: this evaluation will be done at 2 points; at the beginning and the end of the second year of the study (phase 3)
  description: disease progression (indicated by either changes in BICAMS scores or radiological markers of progression) will be compared between MS patients with treated and untreated Insulin resistance
  arm group label: Multiple sclerosis patients without insulin resistance
  description: Cognitive status will be evaluated with BICAMS test. Physical disability will be evaluated by the EDSS score, 9-hole pig and 25-foot-walk test. Patients will be assessed for other comorbid conditions like fatigue and depression. Serum light chain neurofilaments as a laboratory marker for axonal degeneration will be used. brain imaging will be done with with Diffusion tensor imaging.
  arm group label: Multiple sclerosis patients with treated insulin resistance
  description: before and after treatment of insulin resistance Cognitive status will be evaluated with BICAMS test. Physical disability will be evaluated by the EDSS score, 9-hole pig and 25-foot-walk test. Patients will be assessed for other comorbid conditions like fatigue and depression. Serum light chain neurofilaments as a laboratory marker for axonal degeneration will be used. brain imaging will be done with with Diffusion tensor imaging.
  arm group label: Multiple sclerosis patients with untreated insulin resistance
  description: at the end of the 1st and 2nd year of the study, Cognitive status will be evaluated with BICAMS test. Physical disability will be evaluated by the EDSS score, 9-hole pig and 25-foot-walk test. Patients will be assessed for other comorbid conditions like fatigue and depression. Serum light chain neurofilaments as a laboratory marker for axonal degeneration will be used. brain imaging will be done with with Diffusion tensor imaging.
  intervention type: Other
  intervention name: treatment of insulin resistance with appropriate modality according to each patient
  description: insulin resistance will be treated with either diet alone or combined diet and appropriate pharmacological treatment with the net result of normalization of HOMA IR index
  arm group label: Multiple sclerosis patients with treated insulin resistance
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 50 Years
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: doaa mokhtar mahmoud
  investigator title: lecturer
  mesh term: Multiple Sclerosis
  mesh term: Insulin Resistance
  mesh term: Sclerosis
  mesh term: Insulin
  sharing ipd: No