<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/NCT04406402</url>
  </required_header>
  <id_info>
    <org_study_id>03</org_study_id>
    <nct_id>NCT04406402</nct_id>
  </id_info>
  <brief_title>L-arginine and Asymmetric Dimethylarginine (ADMA) and Lifestyle Protocols</brief_title>
  <official_title>The Effects of Different Acute Nutritional Protocols and Lifestyle Modification on Circulating L-arginine and Asymmetric Dimethylarginine (ADMA) in Obese and Type 2 Diabetic Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tel-Aviv Sourasky Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Wolfson Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Tel-Aviv Sourasky Medical Center</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>
      Low serum L-arginine (Arg) and high asymmetric dimethylarginine (ADMA) can predict&#xD;
      microvascular complications in type 2 diabetes (T2DM). The investigators examined whether or&#xD;
      not Arg and ADMA are affected by dietary factors or lifestyle modification in overweight/&#xD;
      obese and T2DM subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators tested the effects on serum Arg and ADMA of a) a single load of ingested&#xD;
      dextrose, protein, fat or alcohol, each consumed within 10 minutes; b) a single episode of&#xD;
      physical exercise; c) a 12 weeks lifestyle modification program comprised of a standard&#xD;
      dietary and physical activity counseling in obese or T2DM subjects on circulating Arg and&#xD;
      ADMA (n=43)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 5, 2006</start_date>
  <completion_date type="Actual">December 10, 2008</completion_date>
  <primary_completion_date type="Actual">April 4, 2008</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Serum L-arginine change</measure>
    <time_frame>For acute phase: before the nutritional/exercise load (time 0), as well as 30, 60, 90, 120 and 150 minutes after the challenge test. And from baseline to 12 weeks for lifestyle modification phase</time_frame>
    <description>Change in arginine levels (absolute and relative) (µmol/l)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>High asymmetric dimethylarginine (ADMA) change</measure>
    <time_frame>For acute phase: before the nutritional/exercise load (time 0), as well as 30, 60, 90, 120 and 150 minutes after the challenge test. And from baseline to 12 weeks for lifestyle modification phase</time_frame>
    <description>Change in ADMA levels (absolute and relative) (µmol/l)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body mass index (BMI) change</measure>
    <time_frame>From baseline to 12 weeks for lifestyle modification phase</time_frame>
    <description>Change in BMI levels (Kg/m2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycated hemoglobin (HbA1c) change</measure>
    <time_frame>From baseline to 12 weeks for lifestyle modification phase</time_frame>
    <description>Change in HbA1c levels (%)</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">243</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <condition>Obesity</condition>
  <condition>Arginine</condition>
  <condition>Asymmetric Dimethylarginine</condition>
  <arm_group>
    <arm_group_label>Acute glucose tolerance test</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A standard oral glucose tolerance test (75 grams of dextrose in 180 cc of water)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Acute protein load test</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A protein-rich, vanilla-flavored powder (Pro-gym, Telpharma, Is</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Acute fat load test</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>a 100-gram portion of sweet cream containing 300 Kacls, of which 94% of the ingested calories were fat</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Acute alcohol load test</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vodka (100 cc, 40% alcohol)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Acute exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>30 minutes of supervised graded walking on a treadmill according to each subject's individual ability. A goal heart rate was calculated as 70% of the age-adjusted maximal allowable heart rate.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lifestyle modification program - 12 weeks</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12 weeks of weight-loss dietary program constructed according to the guidelines of the American Diabetes Association. Based on weight, gender, and age, daily dietary allowance varied at 1200-1800 Kcal, 50% carbohydrates, 20% protein, and 30% fat. Participants were also asked to engage in moderate physical activity comprised of a 40-minute walk three times a week. A weekly clinic visit alternating with a weekly telephone contact was also required.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Acute dietary protocols and lifestyle modification</intervention_name>
    <description>The investigators tested the effects on serum Arg and ADMA of a) a single load of ingested dextrose, protein, fat or alcohol, each consumed within 10 minutes; b) a single episode of physical exercise; c) a 12 weeks lifestyle modification program comprised of a standard dietary and physical activity counseling in obese or T2DM subjects on circulating Arg and ADMA (n=43).</description>
    <arm_group_label>Acute alcohol load test</arm_group_label>
    <arm_group_label>Acute exercise</arm_group_label>
    <arm_group_label>Acute fat load test</arm_group_label>
    <arm_group_label>Acute glucose tolerance test</arm_group_label>
    <arm_group_label>Acute protein load test</arm_group_label>
    <arm_group_label>Lifestyle modification program - 12 weeks</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  obese and/ or T2DM subjects&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  type 1 diabetes&#xD;
&#xD;
          -  insulin-treated T2DM&#xD;
&#xD;
          -  active coronary disease (recent [≤ 6months] myocardial infarction, unstable angina,&#xD;
             recent coronary catheterization, or coronary bypass grafting&#xD;
&#xD;
          -  individuals with significant impairment in liver enzymes (≥ 2.5 the upper limit of the&#xD;
             normal range)&#xD;
&#xD;
          -  serum creatinine higher than 1.5mg%&#xD;
&#xD;
          -  known malabsorption, alcoholism or illicit use of drugs&#xD;
&#xD;
          -  abnormal thyroid function tests&#xD;
&#xD;
          -  concomitant or recent use of glucocorticoids&#xD;
&#xD;
          -  uncertain mental state (to avoid invalid informed consent or lack of compliance).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Naftali Stern, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tel-Aviv Sourasky Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Diabetes Unit, E. Wolfson Medical Center</name>
      <address>
        <city>Holon</city>
        <zip>5822012</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>May 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>May 30, 2020</last_update_submitted>
  <last_update_submitted_qc>May 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</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/NCT04406402
org study id: 03
nct id: NCT04406402
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Low serum L-arginine (Arg) and high asymmetric dimethylarginine (ADMA) can predict
      microvascular complications in type 2 diabetes (T2DM). The investigators examined whether or
      not Arg and ADMA are affected by dietary factors or lifestyle modification in overweight/
      obese and T2DM subjects.
The investigators tested the effects on serum Arg and ADMA of a) a single load of ingested
      dextrose, protein, fat or alcohol, each consumed within 10 minutes; b) a single episode of
      physical exercise; c) a 12 weeks lifestyle modification program comprised of a standard
      dietary and physical activity counseling in obese or T2DM subjects on circulating Arg and
      ADMA (n=43)
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Serum L-arginine change
time frame: For acute phase: before the nutritional/exercise load (time 0), as well as 30, 60, 90, 120 and 150 minutes after the challenge test. And from baseline to 12 weeks for lifestyle modification phase
description: Change in arginine levels (absolute and relative) (µmol/l)
measure: High asymmetric dimethylarginine (ADMA) change
time frame: For acute phase: before the nutritional/exercise load (time 0), as well as 30, 60, 90, 120 and 150 minutes after the challenge test. And from baseline to 12 weeks for lifestyle modification phase
description: Change in ADMA levels (absolute and relative) (µmol/l)
measure: Body mass index (BMI) change
time frame: From baseline to 12 weeks for lifestyle modification phase
description: Change in BMI levels (Kg/m2)
measure: Glycated hemoglobin (HbA1c) change
time frame: From baseline to 12 weeks for lifestyle modification phase
description: Change in HbA1c levels (%)
arm group label: Acute glucose tolerance test
arm group type: Experimental
description: A standard oral glucose tolerance test (75 grams of dextrose in 180 cc of water)
arm group label: Acute protein load test
arm group type: Experimental
description: A protein-rich, vanilla-flavored powder (Pro-gym, Telpharma, Is
arm group label: Acute fat load test
arm group type: Experimental
description: a 100-gram portion of sweet cream containing 300 Kacls, of which 94% of the ingested calories were fat
arm group label: Acute alcohol load test
arm group type: Experimental
description: Vodka (100 cc, 40% alcohol)
arm group label: Acute exercise
arm group type: Experimental
description: 30 minutes of supervised graded walking on a treadmill according to each subject's individual ability. A goal heart rate was calculated as 70% of the age-adjusted maximal allowable heart rate.
arm group label: Lifestyle modification program - 12 weeks
arm group type: Experimental
description: 12 weeks of weight-loss dietary program constructed according to the guidelines of the American Diabetes Association. Based on weight, gender, and age, daily dietary allowance varied at 1200-1800 Kcal, 50% carbohydrates, 20% protein, and 30% fat. Participants were also asked to engage in moderate physical activity comprised of a 40-minute walk three times a week. A weekly clinic visit alternating with a weekly telephone contact was also required.
intervention type: Behavioral
intervention name: Acute dietary protocols and lifestyle modification
description: The investigators tested the effects on serum Arg and ADMA of a) a single load of ingested dextrose, protein, fat or alcohol, each consumed within 10 minutes; b) a single episode of physical exercise; c) a 12 weeks lifestyle modification program comprised of a standard dietary and physical activity counseling in obese or T2DM subjects on circulating Arg and ADMA (n=43).
arm group label: Acute alcohol load test
arm group label: Acute exercise
arm group label: Acute fat load test
arm group label: Acute glucose tolerance test
arm group label: Acute protein load test
arm group label: Lifestyle modification program - 12 weeks
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Naftali Stern, MD
role: Principal Investigator
affiliation: Tel-Aviv Sourasky Medical Center
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No