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/NCT05964751</url>
    </required_header>
    <id_info>
      <org_study_id>soh-Med-23-07-15MS</org_study_id>
      <nct_id>NCT05964751</nct_id>
    </id_info>
    <brief_title>the Association Between Metabolic Syndrome and Its Components With Lupus Nephritis in Systemic Lupus Erythematosus Patients</brief_title>
    <official_title>the Association Between Metabolic Syndrome and Its Components With Lupus Nephritis in Systemic Lupus Erythematosus Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sohag University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sohag 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>
        Systemic lupus erythematosus (SLE) is a heterogeneous autoimmune disease that involve s many&#xD;
        different organs and display a variable clinical course. The prevalence of SLE varies across&#xD;
        gender, race/ethnicity, and geographic regions. SLE demonstrates a striking female&#xD;
        predominance with a peak incidence of disease during the reproductive years. In adults, the&#xD;
        female to male ratio is 10-15:1.&#xD;
  &#xD;
        Clinical features in individual patients can be quite variable and range from mild joint and&#xD;
        skin involvement to severe, life-threatening internal organ disease. Constitutional symptoms,&#xD;
        rash, mucosal ulcers, inflammatory polyarthritis, photosensitivity, and serositis are the&#xD;
        most common clinical features of the disease .&#xD;
  &#xD;
        Major organ affection in SLE includes Neuropsychiatric involvement (cognitive impairment,&#xD;
        depression, psychosis, seizures, stroke, demyelinating syndromes, peripheral neuropathy,&#xD;
        etc.) and cardiopulmonary manifestations. Lupus nephritis is the most common of the&#xD;
        potentially life-threatening manifestations .&#xD;
  &#xD;
        Renal involvement is common in SLE and is a significant cause of morbidity and mortality. It&#xD;
        is estimated that as many as 90% of patients with SLE will have pathologic evidence of renal&#xD;
        involvement on biopsy, but clinically significant nephritis will develop in only 50%.&#xD;
  &#xD;
        Lupus involvement in the kidney manifests as urinary findings (proteinuria, hematuria,&#xD;
        pathologic casts) with or without a rise in serum creatinine. The specific criteria listed&#xD;
        for renal involvement are a urine protein &gt; 500 mg/dL or red blood cell casts, Lupus&#xD;
        nephritis is often confirmed by kidney biopsy, with the results showing one or more of the&#xD;
        classes of lupus nephritis.&#xD;
  &#xD;
        The metabolic syndrome is a prevalent disorder which is defined by the presence of central&#xD;
        obesity, dyslipidemia, hypertension, and disturbed glucose metabolism . It is known that&#xD;
        Metabolic syndrome predisposes to cardiovascular disease (CVD) and consequently, to a rise in&#xD;
        CVD morbidity and mortality. This syndrome plays a major role in the complex network of&#xD;
        systemic pro-inflammatory and prothrombotic states involved in the development of CVD .&#xD;
  &#xD;
        Compared with patients without Metabolic syndrome, SLE patients from the multinational,&#xD;
        multiethnic Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) cohort&#xD;
        with the diagnosis of Metabolic syndrome were older, had a higher disease activity, an&#xD;
        increased number of recent disease flares, and had accrued more organ damage . Mok et al&#xD;
        report that Metabolic syndrome is significantly associated with new organ damage, vascular&#xD;
        events, and mortality in patients with SLE .&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2024</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>lipid profile (triglycerides)</measure>
      <time_frame>1 year</time_frame>
      <description>to detect triglycerides level as apart of diagnosis of metabolic syndrome</description>
    </primary_outcome>
    <primary_outcome>
      <measure>blood pressure measurement</measure>
      <time_frame>1 year</time_frame>
      <description>to detect if patients is hypertinsive or not as apart of diagnosis of metaboic syndrome</description>
    </primary_outcome>
    <primary_outcome>
      <measure>fasting blood suger</measure>
      <time_frame>1 year</time_frame>
      <description>measurment of fasting blood suger to detect hyperglycemia as apart of diagnosis of metaboic syndrome</description>
    </primary_outcome>
    <primary_outcome>
      <measure>body mass index</measure>
      <time_frame>1 year</time_frame>
      <description>measurement of weight &amp; height to detect body mass index as apart of diagnosis of metaboic syndrome</description>
    </primary_outcome>
    <primary_outcome>
      <measure>protein creatinine ratio</measure>
      <time_frame>1 year</time_frame>
      <description>to measure amount of protein in urine as apart of lupus nephritis</description>
    </primary_outcome>
    <primary_outcome>
      <measure>anti nuclear antibody test by IF</measure>
      <time_frame>1 YEAR</time_frame>
      <description>this test to diagnose patient as SLE</description>
    </primary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Lupus Nephritis</condition>
    <arm_group>
      <arm_group_label>patinets with lupus nephritis</arm_group_label>
      <description>patients diagnosed as lupus nehpritis</description>
    </arm_group>
    <arm_group>
      <arm_group_label>pathents without lupus nephritis</arm_group_label>
      <description>sle pathients not diagnosed as lupus nephritis</description>
    </arm_group>
    <arm_group>
      <arm_group_label>controls</arm_group_label>
      <description>controls will be matched for sex, age, and level of schooling withot history of connective tissue disorders, systemic active disease and renal history</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>lipid profile</intervention_name>
      <description>measuerments of lipid profile parameters to detect hyperlipidemia</description>
      <arm_group_label>controls</arm_group_label>
      <arm_group_label>pathents without lupus nephritis</arm_group_label>
      <arm_group_label>patinets with lupus nephritis</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>fasting blood suger</intervention_name>
      <description>measurment of fasting blood suger to detect hyprerglicemia</description>
      <arm_group_label>controls</arm_group_label>
      <arm_group_label>pathents without lupus nephritis</arm_group_label>
      <arm_group_label>patinets with lupus nephritis</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Age less than 18 years . Patient not able and willing to give written informed consent.&#xD;
          Patients with pregnancy, cancer and with viral infectious diseases. Patients with other&#xD;
          autoimmune diseases rather than SLE.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1. Age less than 18 years . 2. Patient not able and willing to give written informed&#xD;
               consent. 3. Patients with pregnancy, cancer and with viral infectious diseases. 4.&#xD;
               Patients with other autoimmune diseases rather than SLE.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1. Age less than 18 years . 2. Patient not able and willing to give written informed&#xD;
               consent. 3. Patients with pregnancy, cancer and with viral infectious diseases. 4.&#xD;
               Patients with other autoimmune diseases rather than SLE.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>mohamed s ali, resident</last_name>
      <phone>01015159035</phone>
      <email>mohamedsalah@med.sohag.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>sahar a al-rahman, assistant professor</last_name>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Sohag university Hospital</name>
        <address>
          <city>Sohag</city>
          <country>Egypt</country>
        </address>
      </facility>
      <contact>
        <last_name>Magdy m Amin, professor</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Pons-Estel GJ, Alarcon GS, Scofield L, Reinlib L, Cooper GS. Understanding the epidemiology and progression of systemic lupus erythematosus. Semin Arthritis Rheum. 2010 Feb;39(4):257-68. doi: 10.1016/j.semarthrit.2008.10.007. Epub 2009 Jan 10.</citation>
      <PMID>19136143</PMID>
    </reference>
    <reference>
      <citation>Lim SS, Bayakly AR, Helmick CG, Gordon C, Easley KA, Drenkard C. The incidence and prevalence of systemic lupus erythematosus, 2002-2004: The Georgia Lupus Registry. Arthritis Rheumatol. 2014 Feb;66(2):357-68. doi: 10.1002/art.38239.</citation>
      <PMID>24504808</PMID>
    </reference>
    <reference>
      <citation>DUBOIS EL, TUFFANELLI DL. CLINICAL MANIFESTATIONS OF SYSTEMIC LUPUS ERYTHEMATOSUS. COMPUTER ANALYSIS OF 520 CASES. JAMA. 1964 Oct 12;190:104-11. doi: 10.1001/jama.1964.03070150014003. No abstract available.</citation>
      <PMID>14184513</PMID>
    </reference>
    <reference>
      <citation>Hahn BH, McMahon MA, Wilkinson A, Wallace WD, Daikh DI, Fitzgerald JD, Karpouzas GA, Merrill JT, Wallace DJ, Yazdany J, Ramsey-Goldman R, Singh K, Khalighi M, Choi SI, Gogia M, Kafaja S, Kamgar M, Lau C, Martin WJ, Parikh S, Peng J, Rastogi A, Chen W, Grossman JM; American College of Rheumatology. American College of Rheumatology guidelines for screening, treatment, and management of lupus nephritis. Arthritis Care Res (Hoboken). 2012 Jun;64(6):797-808. doi: 10.1002/acr.21664. No abstract available.</citation>
      <PMID>22556106</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sohag University</investigator_affiliation>
      <investigator_full_name>Mohamed Salah Eldin Ali</investigator_full_name>
      <investigator_title>resident at rheumatology and rehabilitation department</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Nephritis</mesh_term>
      <mesh_term>Lupus Nephritis</mesh_term>
      <mesh_term>Lupus Erythematosus, Systemic</mesh_term>
      <mesh_term>Metabolic Syndrome</mesh_term>
    </condition_browse>
    <!-- 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/NCT05964751
  org study id: soh-Med-23-07-15MS
  nct id: NCT05964751
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Systemic lupus erythematosus (SLE) is a heterogeneous autoimmune disease that involve s many
        different organs and display a variable clinical course. The prevalence of SLE varies across
        gender, race/ethnicity, and geographic regions. SLE demonstrates a striking female
        predominance with a peak incidence of disease during the reproductive years. In adults, the
        female to male ratio is 10-15:1.
  
        Clinical features in individual patients can be quite variable and range from mild joint and
        skin involvement to severe, life-threatening internal organ disease. Constitutional symptoms,
        rash, mucosal ulcers, inflammatory polyarthritis, photosensitivity, and serositis are the
        most common clinical features of the disease .
  
        Major organ affection in SLE includes Neuropsychiatric involvement (cognitive impairment,
        depression, psychosis, seizures, stroke, demyelinating syndromes, peripheral neuropathy,
        etc.) and cardiopulmonary manifestations. Lupus nephritis is the most common of the
        potentially life-threatening manifestations .
  
        Renal involvement is common in SLE and is a significant cause of morbidity and mortality. It
        is estimated that as many as 90% of patients with SLE will have pathologic evidence of renal
        involvement on biopsy, but clinically significant nephritis will develop in only 50%.
  
        Lupus involvement in the kidney manifests as urinary findings (proteinuria, hematuria,
        pathologic casts) with or without a rise in serum creatinine. The specific criteria listed
        for renal involvement are a urine protein > 500 mg/dL or red blood cell casts, Lupus
        nephritis is often confirmed by kidney biopsy, with the results showing one or more of the
        classes of lupus nephritis.
  
        The metabolic syndrome is a prevalent disorder which is defined by the presence of central
        obesity, dyslipidemia, hypertension, and disturbed glucose metabolism . It is known that
        Metabolic syndrome predisposes to cardiovascular disease (CVD) and consequently, to a rise in
        CVD morbidity and mortality. This syndrome plays a major role in the complex network of
        systemic pro-inflammatory and prothrombotic states involved in the development of CVD .
  
        Compared with patients without Metabolic syndrome, SLE patients from the multinational,
        multiethnic Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) cohort
        with the diagnosis of Metabolic syndrome were older, had a higher disease activity, an
        increased number of recent disease flares, and had accrued more organ damage . Mok et al
        report that Metabolic syndrome is significantly associated with new organ damage, vascular
        events, and mortality in patients with SLE .
  observational model: Case-Control
  time perspective: Retrospective
  measure: lipid profile (triglycerides)
  time frame: 1 year
  description: to detect triglycerides level as apart of diagnosis of metabolic syndrome
  measure: blood pressure measurement
  time frame: 1 year
  description: to detect if patients is hypertinsive or not as apart of diagnosis of metaboic syndrome
  measure: fasting blood suger
  time frame: 1 year
  description: measurment of fasting blood suger to detect hyperglycemia as apart of diagnosis of metaboic syndrome
  measure: body mass index
  time frame: 1 year
  description: measurement of weight & height to detect body mass index as apart of diagnosis of metaboic syndrome
  measure: protein creatinine ratio
  time frame: 1 year
  description: to measure amount of protein in urine as apart of lupus nephritis
  measure: anti nuclear antibody test by IF
  time frame: 1 YEAR
  description: this test to diagnose patient as SLE
  arm group label: patinets with lupus nephritis
  description: patients diagnosed as lupus nehpritis
  arm group label: pathents without lupus nephritis
  description: sle pathients not diagnosed as lupus nephritis
  arm group label: controls
  description: controls will be matched for sex, age, and level of schooling withot history of connective tissue disorders, systemic active disease and renal history
  intervention type: Diagnostic Test
  intervention name: lipid profile
  description: measuerments of lipid profile parameters to detect hyperlipidemia
  arm group label: controls
  arm group label: pathents without lupus nephritis
  arm group label: patinets with lupus nephritis
  intervention type: Diagnostic Test
  intervention name: fasting blood suger
  description: measurment of fasting blood suger to detect hyprerglicemia
  arm group label: controls
  arm group label: pathents without lupus nephritis
  arm group label: patinets with lupus nephritis
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: mohamed s ali, resident
  phone: 01015159035
  email: mohamedsalah@med.sohag.edu.eg
  last name: sahar a al-rahman, assistant professor
  facility: 
  contact: 
  country: Egypt
  citation: Pons-Estel GJ, Alarcon GS, Scofield L, Reinlib L, Cooper GS. Understanding the epidemiology and progression of systemic lupus erythematosus. Semin Arthritis Rheum. 2010 Feb;39(4):257-68. doi: 10.1016/j.semarthrit.2008.10.007. Epub 2009 Jan 10.
  PMID: 19136143
  citation: Lim SS, Bayakly AR, Helmick CG, Gordon C, Easley KA, Drenkard C. The incidence and prevalence of systemic lupus erythematosus, 2002-2004: The Georgia Lupus Registry. Arthritis Rheumatol. 2014 Feb;66(2):357-68. doi: 10.1002/art.38239.
  PMID: 24504808
  citation: DUBOIS EL, TUFFANELLI DL. CLINICAL MANIFESTATIONS OF SYSTEMIC LUPUS ERYTHEMATOSUS. COMPUTER ANALYSIS OF 520 CASES. JAMA. 1964 Oct 12;190:104-11. doi: 10.1001/jama.1964.03070150014003. No abstract available.
  PMID: 14184513
  citation: Hahn BH, McMahon MA, Wilkinson A, Wallace WD, Daikh DI, Fitzgerald JD, Karpouzas GA, Merrill JT, Wallace DJ, Yazdany J, Ramsey-Goldman R, Singh K, Khalighi M, Choi SI, Gogia M, Kafaja S, Kamgar M, Lau C, Martin WJ, Parikh S, Peng J, Rastogi A, Chen W, Grossman JM; American College of Rheumatology. American College of Rheumatology guidelines for screening, treatment, and management of lupus nephritis. Arthritis Care Res (Hoboken). 2012 Jun;64(6):797-808. doi: 10.1002/acr.21664. No abstract available.
  PMID: 22556106
  responsible party type: Principal Investigator
  investigator affiliation: Sohag University
  investigator full name: Mohamed Salah Eldin Ali
  investigator title: resident at rheumatology and rehabilitation department
  mesh term: Nephritis
  mesh term: Lupus Nephritis
  mesh term: Lupus Erythematosus, Systemic
  mesh term: Metabolic Syndrome