<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/NCT04485845</url>
  </required_header>
  <id_info>
    <org_study_id>IDE00218</org_study_id>
    <nct_id>NCT04485845</nct_id>
  </id_info>
  <brief_title>Metformin Versus Vildagliptin in Reducing Risk of Metabolic Syndrome Complications Progression</brief_title>
  <official_title>Comparative Effecacy of Metformin and Vildagliptin on Cardiometabolic Risk Factors, Metabolic Syndrome, and Diabetic Nephropathy Progression</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>
      Several crosssectional and prospective studies have shown that metabolic syndrome and its&#xD;
      related components are associated with both prevalent and incident CKD .&#xD;
&#xD;
      Although the mechanisms for these cardiovascular benefits of Metformin and vildagliptin&#xD;
      remain unclear, they extend well beyond glycemic lowering, and therefore are probably best&#xD;
      considered diverse &quot;cardiometabolic&quot; pharmaceuticals rather than simply type 2 diabetes&#xD;
      drugs.&#xD;
&#xD;
      Metformin and vildagliptin have known vasculoprotective actions, but the value of these drugs&#xD;
      on drug-naïve diabetic patients during 24 week use warrants investigation. The investigator's&#xD;
      purpose was to observe their effects on weight control, Cardiometabolic Risk Factors,&#xD;
      Metabolic Syndrome risk, and diabetic nephrooathy Progression.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      the current study is investigating the relation betweeneach componant of metabolic syndrome&#xD;
      and kidney injury incidence or prevalence, and the mechanism of its occurence. the kidney&#xD;
      protective effect of metformin and vildagliptin and the mechanism of this action whether it&#xD;
      is related to their glucose lowering mechanism or not is also one of the important points to&#xD;
      be investigated in the study&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 1, 2019</start_date>
  <completion_date type="Anticipated">September 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 30, 2020</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>progression of metabolic syndrome complications</measure>
    <time_frame>24 weeks</time_frame>
    <description>investigate the effect of antidiabetic drugs on improving patients' cases and reduce complcations of metablic syndrome and that will be assessed by measuring glucose serum levels, insulin plasma levels to calculate insulin resistance by HOMA-ir</description>
  </primary_outcome>
  <primary_outcome>
    <measure>estimation of metabolic syndrome deterioration</measure>
    <time_frame>24 weeks</time_frame>
    <description>study the effect of both antidiabetic drugs on blood pressure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>reduce nephropathic impairement</measure>
    <time_frame>24 weeks</time_frame>
    <description>study the impact of both metformin and vildagliptin on reducing kidney deterioration for patients suffering from metabolic syndrome and that can be assessed by measuring kidney function serologically using ELISA kits for each parameter</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">39</enrollment>
  <condition>Metabolic Syndrome</condition>
  <condition>Diabete Type 2</condition>
  <condition>Kidney Insufficiency</condition>
  <arm_group>
    <arm_group_label>metformin treated group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A group of patients treated with a daily dose of metformin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>vildagliptin treated group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A group of patients treated with a daily dose of vildagliptin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vildagliptin</intervention_name>
    <description>to compare the effect of both metformin and vildagliptin on the progression of diabetes and metabolic complications and risk factors</description>
    <arm_group_label>vildagliptin treated group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Captopril Tablets</intervention_name>
    <description>used to treat hypertension in metabolic syndrome patients and as a renal protector</description>
    <arm_group_label>metformin treated group</arm_group_label>
    <arm_group_label>vildagliptin treated group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MetFORMIN 500 Mg Oral Tablet</intervention_name>
    <description>antihyperglycemic drug for elevated plasma glucose level and help in weight loss for patients suffering from diabetes or metabolic syndrome</description>
    <arm_group_label>metformin treated group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. men or women 40-70 years of age&#xD;
&#xD;
          2. body mass index be-tween≥22 and ≤40 kg/m2.&#xD;
&#xD;
          3. DM with an HbA1c ≥ 7&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        (1) pregnant or nursing women; (2) chronic (&gt;7 consecutive days) oral, parenteral or&#xD;
        intra-articular corticosteroid treatment within 8 weeks prior to Visit 1 (3) history or&#xD;
        evidence of major hepatopathy (aspartate aminotransferase or alanineaminotransferase&#xD;
        activities &gt; 2.5 times the upper limit of normal) (4) ischemic heart disease or&#xD;
        cerebrovascular disease (5) creatinine level &gt; 0.133 mmol/L (6) major diabetes&#xD;
        complications (chronic renal insufficiency, proliferative retinopathy and stroke); (7)&#xD;
        extreme dyslipidemia, such as familial hypercholesterolaemia&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dalia Zaafar, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lecturer of clinical pharmacology and toxicology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dalia Zaafar, PhD</last_name>
    <phone>00201117922833</phone>
    <email>dalia.zaffar@pharm.mti.edu.eg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>soha hassanin, PhD</last_name>
    <email>phsoha@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>National Diabetes &amp; Endocrinology Institute</name>
      <address>
        <city>Cairo</city>
        <zip>11311</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>dalia zaafar, phd</last_name>
    </contact>
    <contact_backup>
      <last_name>soha hassanin, phd</last_name>
    </contact_backup>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>March 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>July 21, 2020</last_update_submitted>
  <last_update_submitted_qc>July 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Dalia K. Zaafar</investigator_full_name>
    <investigator_title>lecturer of pharmacology</investigator_title>
  </responsible_party>
  <keyword>metfomin</keyword>
  <keyword>vildagliptin</keyword>
  <keyword>metabolic syndrome</keyword>
  <keyword>T2DM</keyword>
  <keyword>nephropathy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metformin</mesh_term>
    <mesh_term>Vildagliptin</mesh_term>
    <mesh_term>Captopril</mesh_term>
  </intervention_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/NCT04485845
org study id: IDE00218
nct id: NCT04485845
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Several crosssectional and prospective studies have shown that metabolic syndrome and its
      related components are associated with both prevalent and incident CKD .

      Although the mechanisms for these cardiovascular benefits of Metformin and vildagliptin
      remain unclear, they extend well beyond glycemic lowering, and therefore are probably best
      considered diverse "cardiometabolic" pharmaceuticals rather than simply type 2 diabetes
      drugs.

      Metformin and vildagliptin have known vasculoprotective actions, but the value of these drugs
      on drug-naïve diabetic patients during 24 week use warrants investigation. The investigator's
      purpose was to observe their effects on weight control, Cardiometabolic Risk Factors,
      Metabolic Syndrome risk, and diabetic nephrooathy Progression.
the current study is investigating the relation betweeneach componant of metabolic syndrome
      and kidney injury incidence or prevalence, and the mechanism of its occurence. the kidney
      protective effect of metformin and vildagliptin and the mechanism of this action whether it
      is related to their glucose lowering mechanism or not is also one of the important points to
      be investigated in the study
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: progression of metabolic syndrome complications
time frame: 24 weeks
description: investigate the effect of antidiabetic drugs on improving patients' cases and reduce complcations of metablic syndrome and that will be assessed by measuring glucose serum levels, insulin plasma levels to calculate insulin resistance by HOMA-ir
measure: estimation of metabolic syndrome deterioration
time frame: 24 weeks
description: study the effect of both antidiabetic drugs on blood pressure
measure: reduce nephropathic impairement
time frame: 24 weeks
description: study the impact of both metformin and vildagliptin on reducing kidney deterioration for patients suffering from metabolic syndrome and that can be assessed by measuring kidney function serologically using ELISA kits for each parameter
arm group label: metformin treated group
arm group type: Active Comparator
description: A group of patients treated with a daily dose of metformin
arm group label: vildagliptin treated group
arm group type: Experimental
description: A group of patients treated with a daily dose of vildagliptin
intervention type: Drug
intervention name: Vildagliptin
description: to compare the effect of both metformin and vildagliptin on the progression of diabetes and metabolic complications and risk factors
arm group label: vildagliptin treated group
intervention type: Drug
intervention name: Captopril Tablets
description: used to treat hypertension in metabolic syndrome patients and as a renal protector
arm group label: metformin treated group
arm group label: vildagliptin treated group
intervention type: Drug
intervention name: MetFORMIN 500 Mg Oral Tablet
description: antihyperglycemic drug for elevated plasma glucose level and help in weight loss for patients suffering from diabetes or metabolic syndrome
arm group label: metformin treated group
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: No
last name: Dalia Zaafar, PhD
role: Principal Investigator
affiliation: Lecturer of clinical pharmacology and toxicology
last name: Dalia Zaafar, PhD
phone: 00201117922833
email: dalia.zaffar@pharm.mti.edu.eg
last name: soha hassanin, PhD
email: phsoha@hotmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Dalia K. Zaafar
investigator title: lecturer of pharmacology
mesh term: Renal Insufficiency
mesh term: Metabolic Syndrome
mesh term: Diabetes Mellitus, Type 2
mesh term: Syndrome
mesh term: Metformin
mesh term: Vildagliptin
mesh term: Captopril
sharing ipd: No