<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/NCT03820102</url>
  </required_header>
  <id_info>
    <org_study_id>IR,VitD in HCV</org_study_id>
    <nct_id>NCT03820102</nct_id>
  </id_info>
  <brief_title>Impact of Metabolic Changes and Vitamin D Status on Virological Response in Patients With HCV Infection Treated by DAAs</brief_title>
  <official_title>Impact of Metabolic Changes and Vitamin D Status on Virological Response in Patients With Hepatitis C Viral Infection Treated by Direct Acting Antiviral Drugs</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut 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>
      1. Study Changes in lipid profile and the impact of Insulin resistance on virological&#xD;
           response in patients with Hepatitis C viral infection treated by Direct Acting Antiviral&#xD;
           agents&#xD;
&#xD;
        2. The assessment of serum vitamin D levels in HCV infected patients and predictive value&#xD;
           of pre-treatment serum vitamin D level for achieving sustained virological response at&#xD;
           12 weeks post-treatment&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients and methods:&#xD;
&#xD;
      This cross-sectional study will include 100patients of chronic HCV infection who attend El&#xD;
      Raghy Assiut university Hospital, either inpatients or outpatients. Chronic HCV infection&#xD;
      will be diagnosed based on detectable HCV RNA with anti-HCV Ab in patient with clinical&#xD;
      and/or ultrasonographic criteria of chronic liver disease.&#xD;
&#xD;
      Patients will receive treatment to HCV by DAAs and follow up for 12 weeks to confirm&#xD;
      sustained virological response&#xD;
&#xD;
      Method:&#xD;
&#xD;
      Patients presenting in this study will be subjected to the following:&#xD;
&#xD;
        1. Full history and clinical evaluation.&#xD;
&#xD;
        2. Body weight (kg) and height (m).&#xD;
&#xD;
        3. BMI will calculate as weight divided by squared height (kg/m2).&#xD;
&#xD;
        4. Waist circumference will measured at a level midway between the lowest rib and the iliac&#xD;
           crest, and the hip circumference at the level of the great trochanters, with the legs&#xD;
           close together.&#xD;
&#xD;
        5. Blood pressure (mmHg) was measured twice in the upper arm after a 10-min period of rest&#xD;
           and taken an average.&#xD;
&#xD;
      Laboratory investigations will include:&#xD;
&#xD;
        -  Complete blood count (CBC)&#xD;
&#xD;
        -  Liver function test&#xD;
&#xD;
        -  HCV Ab and HCV RNA by PCR&#xD;
&#xD;
        -  HBs Ag&#xD;
&#xD;
        -  Alpha fetoprotein&#xD;
&#xD;
        -  Lipid profile&#xD;
&#xD;
        -  Serum urea and creatinine&#xD;
&#xD;
        -  Fasting blood sugar (FBG)and Serum fasting insulin level&#xD;
&#xD;
        -  Insulin resistance determined via Homeostasis Model Assessment (HOMA-IR) IR = fasting&#xD;
           insulin (µu/ml) × fasting glucose (mmol/L)&#xD;
           ----------------------------------------------------------------- 22.5 An index value of&#xD;
           ˃ 2. 5 was defined as IR (Huang et al., 2011)&#xD;
&#xD;
        -  Vitamin D level:&#xD;
&#xD;
      Vitamin D deficiency wasdefined as a 25 (OH)-vitamin D serum level &lt; 20 ng/mL, vitaminD&#xD;
      insufficiency as 25 (OH)-vitamin D levels of 20 - 29.9ng/mL, and normal vitamin D levels ≥ 30&#xD;
      ng/mL (Holick MF et al.,2011)&#xD;
&#xD;
        -  Abdominal Ultrasound&#xD;
&#xD;
        -  Electrocardiogram (ECG)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 2019</start_date>
  <completion_date type="Anticipated">October 2019</completion_date>
  <primary_completion_date type="Anticipated">September 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>SVR12</measure>
    <time_frame>12 week after treatment</time_frame>
    <description>sustained virological response 12 week after treatment</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>HCV</condition>
  <arm_group>
    <arm_group_label>Vit D deficiency</arm_group_label>
    <description>Chronic HCV patients with vitamin D deficiency Sustained virological response after treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal Vit D</arm_group_label>
    <description>Chronic HCV patients with normal vitamin D level Sustained virological response after treatment</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        1. Full history and clinical evaluation.&#xD;
&#xD;
          2. Body weight and height&#xD;
&#xD;
          3. BMI will calculate as weight divided by squared height (kg/m2)&#xD;
&#xD;
          4. Waist circumference&#xD;
&#xD;
          5. Blood pressure (mmHg)&#xD;
&#xD;
        Laboratory investigations will include:&#xD;
&#xD;
          -  Complete blood count (CBC)&#xD;
&#xD;
          -  Liver function test&#xD;
&#xD;
          -  HCV Ab and HCV RNA by PCR&#xD;
&#xD;
          -  HBs Ag&#xD;
&#xD;
          -  Alpha fetoprotein&#xD;
&#xD;
          -  Lipid profile&#xD;
&#xD;
          -  Serum urea and creatinine&#xD;
&#xD;
          -  Fasting blood sugar and Serum fasting insulin level&#xD;
&#xD;
          -  Insulin resistance determined via Homeostasis Model Assessment (HOMA-IR) IR = fasting&#xD;
             insulin (µu/ml) × fasting glucose (mmol/L)&#xD;
&#xD;
        22.5 An index value of ˃ 2. 5 was defined as IR (Huang et al., 2011)&#xD;
&#xD;
          -  Vitamin D level:&#xD;
&#xD;
          -  Abdominal Ultrasound&#xD;
&#xD;
          -  Electrocardiogram&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic HCV will receive DAAs for treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Decompensated liver cirrhosis, hepatocellular carcinoma, history of liver transplant&#xD;
&#xD;
          2. Co-existing liver disease (hepatitis B virus, autoimmune hepatitis, human&#xD;
             immunodeficiency virus)&#xD;
&#xD;
          3. Extra-hepatic malignancy except after two years of disease free interval.&#xD;
&#xD;
          4. Patients with diabetes mellitus.&#xD;
&#xD;
          5. Patients with Chronic kidney disease.&#xD;
&#xD;
          6. Pregnancy or in ability to use effective contraception.&#xD;
&#xD;
          7. Patients with history of using lipid lowering therapy&#xD;
&#xD;
          8. relapser or failure of previous HCV treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Laila Abd Elbaky, profesor</last_name>
    <role>Study Chair</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mohamed H Abdelgawad, specialist</last_name>
    <phone>01008778754</phone>
    <email>d_m_h_80@hotmail.com</email>
  </overall_contact>
  <results_reference>
    <citation>Janovy J Jr. Problems in the comparative physiology of some trypanosomatid flagellates. Acta Trop. 1977 Jun;34(2):177-84.</citation>
    <PMID>19960</PMID>
  </results_reference>
  <results_reference>
    <citation>Selhub J, Rosenberg IH. Demonstration of high-affinity folate binding activity associated with the brush border membranes of rat kidney. Proc Natl Acad Sci U S A. 1978 Jul;75(7):3090-3. doi: 10.1073/pnas.75.7.3090.</citation>
    <PMID>28521</PMID>
  </results_reference>
  <results_reference>
    <citation>Ramachandran N, Colman RF. Evidence for a critical glutamyl and an aspartyl residue in the function of pig heart diphosphopyridine nucleotide dependent isocitrate dehydrogenase. Biochemistry. 1977 Apr 19;16(8):1564-73. doi: 10.1021/bi00627a006.</citation>
    <PMID>15585</PMID>
  </results_reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>February 3, 2019</last_update_submitted>
  <last_update_submitted_qc>February 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mohamed Hassan Abdelgawad</investigator_full_name>
    <investigator_title>Gastroenterologest and hepatologest, doctor in Assiut Police Hospital</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03820102
org study id: IR,VitD in HCV
nct id: NCT03820102
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
1. Study Changes in lipid profile and the impact of Insulin resistance on virological
           response in patients with Hepatitis C viral infection treated by Direct Acting Antiviral
           agents

        2. The assessment of serum vitamin D levels in HCV infected patients and predictive value
           of pre-treatment serum vitamin D level for achieving sustained virological response at
           12 weeks post-treatment
Patients and methods:

      This cross-sectional study will include 100patients of chronic HCV infection who attend El
      Raghy Assiut university Hospital, either inpatients or outpatients. Chronic HCV infection
      will be diagnosed based on detectable HCV RNA with anti-HCV Ab in patient with clinical
      and/or ultrasonographic criteria of chronic liver disease.

      Patients will receive treatment to HCV by DAAs and follow up for 12 weeks to confirm
      sustained virological response

      Method:

      Patients presenting in this study will be subjected to the following:

        1. Full history and clinical evaluation.

        2. Body weight (kg) and height (m).

        3. BMI will calculate as weight divided by squared height (kg/m2).

        4. Waist circumference will measured at a level midway between the lowest rib and the iliac
           crest, and the hip circumference at the level of the great trochanters, with the legs
           close together.

        5. Blood pressure (mmHg) was measured twice in the upper arm after a 10-min period of rest
           and taken an average.

      Laboratory investigations will include:

        -  Complete blood count (CBC)

        -  Liver function test

        -  HCV Ab and HCV RNA by PCR

        -  HBs Ag

        -  Alpha fetoprotein

        -  Lipid profile

        -  Serum urea and creatinine

        -  Fasting blood sugar (FBG)and Serum fasting insulin level

        -  Insulin resistance determined via Homeostasis Model Assessment (HOMA-IR) IR = fasting
           insulin (µu/ml) × fasting glucose (mmol/L)
           ----------------------------------------------------------------- 22.5 An index value of
           ˃ 2. 5 was defined as IR (Huang et al., 2011)

        -  Vitamin D level:

      Vitamin D deficiency wasdefined as a 25 (OH)-vitamin D serum level < 20 ng/mL, vitaminD
      insufficiency as 25 (OH)-vitamin D levels of 20 - 29.9ng/mL, and normal vitamin D levels ≥ 30
      ng/mL (Holick MF et al.,2011)

        -  Abdominal Ultrasound

        -  Electrocardiogram (ECG)
observational model: Cohort
time perspective: Cross-Sectional
measure: SVR12
time frame: 12 week after treatment
description: sustained virological response 12 week after treatment
arm group label: Vit D deficiency
description: Chronic HCV patients with vitamin D deficiency Sustained virological response after treatment
arm group label: Normal Vit D
description: Chronic HCV patients with normal vitamin D level Sustained virological response after treatment
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Laila Abd Elbaky, profesor
role: Study Chair
affiliation: Assiut University
last name: Mohamed H Abdelgawad, specialist
phone: 01008778754
email: d_m_h_80@hotmail.com
citation: Janovy J Jr. Problems in the comparative physiology of some trypanosomatid flagellates. Acta Trop. 1977 Jun;34(2):177-84.
PMID: 19960
citation: Selhub J, Rosenberg IH. Demonstration of high-affinity folate binding activity associated with the brush border membranes of rat kidney. Proc Natl Acad Sci U S A. 1978 Jul;75(7):3090-3. doi: 10.1073/pnas.75.7.3090.
PMID: 28521
citation: Ramachandran N, Colman RF. Evidence for a critical glutamyl and an aspartyl residue in the function of pig heart diphosphopyridine nucleotide dependent isocitrate dehydrogenase. Biochemistry. 1977 Apr 19;16(8):1564-73. doi: 10.1021/bi00627a006.
PMID: 15585
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mohamed Hassan Abdelgawad
investigator title: Gastroenterologest and hepatologest, doctor in Assiut Police Hospital
mesh term: Infections
sharing ipd: No