<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/NCT02262208</url>
  </required_header>
  <id_info>
    <org_study_id>120148</org_study_id>
    <nct_id>NCT02262208</nct_id>
  </id_info>
  <brief_title>Exercise as a Tool for Studying the Mechanisms and Applicability of Glycemic Variability</brief_title>
  <acronym>ETSMAGV</acronym>
  <official_title>Exercise as a Tool for Studying the Mechanisms and Applicability of Glycemic Variability in Individuals With and Without Type 2 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Clinicas de Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital de Clinicas de Porto Alegre</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim this study is characterize glycemic variability using linear and nonlinear&#xD;
      mathematical tools, under basal conditions and in response to specific protocols acute&#xD;
      exercise that evoke oxidative stress and inflammation in healthy subjects and type 2 diabetes&#xD;
      patients. For this purpose, the sample size will consist of 37 individuals healthy and 32&#xD;
      without type 2 diabetes mellitus wore a CGMS during 3 days. Participants randomly performed&#xD;
      aerobic and eccentric sessions, both in the morning (24h after CGMS placement), and at least&#xD;
      7 days apart. Glucose variability was evaluated by glucose standard deviation, glucose&#xD;
      variance, mean amplitude of glycemic excursions (MAGE), and glucose coefficient of variation&#xD;
      (conventional methods) as well as by spectral and symbolic analysis (non-conventional&#xD;
      methods). Physiological mechanisms altered by exercise protocols (Human Soluble Interleukin-6&#xD;
      and Glutathione), will be measured in blood samples.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim this study is characterize glycemic variability using linear and nonlinear&#xD;
      mathematical tools, under basal conditions and in response to specific protocols acute&#xD;
      exercise that evoke oxidative stress and inflammation in healthy subjects and type 2 diabetes&#xD;
      patients. For this purpose, the sample size will consist of 37 individuals healthy and 32&#xD;
      without type 2 diabetes mellitus, which will undertake the two types of exercise, randomly&#xD;
      distributed. The maximal incremental exercise test will be performed in electrically braked&#xD;
      cycle ergometer (ER-900, Jaeger, Wu¨ rzburg, Germany) in order to assess possible&#xD;
      contraindications to the proposed protocol as well functional capacity, which will be used in&#xD;
      prescription of the aerobic exercise session and a testing strength maximal will be conducted&#xD;
      and used in the prescription of the eccentric exercise session.&#xD;
&#xD;
      The glucose variability will be assessed by continuous glucose monitoring system (CGMS)&#xD;
      during 72h. Glucose variability will be evaluated by glucose standard deviation, glucose&#xD;
      variance, mean amplitude of glycemic excursions (MAGE), and glucose coefficient of variation&#xD;
      (conventional methods) as well as by spectral and symbolic analysis (non-conventional&#xD;
      methods). Physiological mechanisms altered by exercise protocols will be measured in blood&#xD;
      samples., Human Soluble Interleukin-6 ( HU IL 6 ELISA KIT - BIOSOURCE) and Glutathione (GSH)&#xD;
      indicator of oxidative stress (GSH assay in: Rahman I, Kode A, Biswas SK. Nat Protoc.&#xD;
      2006;1(6):3159-65). The aerobic session will consist of 40 min of lower limb bicycle at 70%&#xD;
      of the peak heart rate, as determined in the incremental exercise test and eccentric session&#xD;
      will consist of 40 min of one lower -limb exercises (leg press) with 6 sets of 10 repetitions&#xD;
      at 120% of 1-RM. The protocol was approved by the Ethics in Research Committee at Hospital de&#xD;
      Clínicas de Porto Alegre and all patients will provide their written informed consent before&#xD;
      the participation.The research will be performed at the Exercise Pathophysiology Research&#xD;
      laboratory of the Hospital de Clínicas de Porto Alegre. We believe that signs of glycemic&#xD;
      variability has characteristics detectable by alternative, related to hysiological processes&#xD;
      such as oxidative stress and inflammation, evoked by aerobic and eccentric exercise protocols&#xD;
      mathematical methods, may help explain the acute response of healthy individuals and patients&#xD;
      with type 2 diabetes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2014</start_date>
  <completion_date type="Anticipated">August 2015</completion_date>
  <primary_completion_date type="Anticipated">July 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Glycemic variability by continuous glucose monitoring system</measure>
    <time_frame>The monitor that analyzes the data every 10s and reports average values every 5 min, totalizing 288 readings per day. Glucose profiles will be collected the day before (day 1), the day of (day 2), and the day following (day 3) of 40 min of both exercise.</time_frame>
    <description>Will be assessed conventional and non-conventional methods to analyze glucose variability derived from multiple measurements performed with continuous glucose monitoring system (CGMS).Subjects will be admitted to the laboratory in the morning at approximately 9:00 a.m., 24 h before the exercise session, when the glucose sensor (Sof-SensorTM, Medtronic Mini-Med, Northridge, USA) will be inserted subcutaneously. The sensor is a glucose oxidase based platinum electrode that is inserted through a needle into the subcutaneous tissue of the anterior abdominal wall, using a spring-loaded device (Senserter, Medtronic, Northridge, USA). Glucose profiles will be collected the day before (day 1), the day of (day 2), and the day following (day 3) and 40 min of exercise. Each sensor will be used continuously for up to 72 h.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oxidative stress</measure>
    <time_frame>10 minutes before the exercise sessions and 10 minutes after the exercise sessions.</time_frame>
    <description>Will be assessed by Glutathione (GSH) indicator of oxidative stress (GSH assay in: Rahman I, Kode A, Biswas SK Nat PROTOC 2006, 1 (6): 3159-65.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">69</enrollment>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Patients with type 2 diabetes</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Aerobic Exercises</intervention_name>
    <description>Exercise intensity for each individual by a heart rate monitor (Polar F1 TM, Polar Electro Oy, Helsinki, Finland), and a Borg 0-10 scale used to register individuals' perceived exertion every 5 minutes throughout the experimental sessions.&#xD;
Aerobic session will consist of 40 min of lower limb bicycle at 70% of the peak heart rate, as determined in the incremental exercise test.</description>
    <arm_group_label>Healthy</arm_group_label>
    <arm_group_label>Patients with type 2 diabetes</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Eccentric Exercise</intervention_name>
    <description>Eccentric session will consist of 40 min of one lower -limb exercises (leg press) with 6 sets of 10 repetitions at 120% of 1-RM.</description>
    <arm_group_label>Healthy</arm_group_label>
    <arm_group_label>Patients with type 2 diabetes</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Continuous glucose monitoring system (Guardian, Medtronic, Northridge, USA)</intervention_name>
    <description>Subjects will be admitted to the laboratory in the morning at approximately 9:00 a.m., 24 h before the exercise session, when the glucose sensor (Sof-SensorTM, Medtronic Mini-Med, Northridge, USA) will be inserted subcutaneously. The sensor is a glucose oxidase based platinum electrode that is inserted through a needle into the subcutaneous tissue of the anterior abdominal wall, using a spring-loaded device (Senserter, Medtronic, Northridge, USA). Glucose profiles will be collected the day before (day 1), the day of (day 2), and the day following (day 3) and 40 min of exercise. Each sensor will be used continuously for up to 72 h.</description>
    <arm_group_label>Healthy</arm_group_label>
    <arm_group_label>Patients with type 2 diabetes</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Type 2 diabetes Male and female 18-65 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Chronic kidney failure; Limb amputation Diabetic proliferative retinopathy; Regular&#xD;
        physical training; Severe autonomic neuropathy; Diabetic nephropathy established; Coronary&#xD;
        artery disease; Heart failure; Uncontrolled hypertension Treatment of insulin&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital de Clinicas de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <zip>90035-003</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marcia Raymundo, PhD</last_name>
      <phone>+55 51 21 01 8304</phone>
      <email>mraymundo@hcpa.ufrgs.br</email>
    </contact>
    <investigator>
      <last_name>Beatriz Schaan, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Rahman I, Kode A, Biswas SK. Assay for quantitative determination of glutathione and glutathione disulfide levels using enzymatic recycling method. Nat Protoc. 2006;1(6):3159-65. doi: 10.1038/nprot.2006.378.</citation>
    <PMID>17406579</PMID>
  </reference>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>October 13, 2014</last_update_submitted>
  <last_update_submitted_qc>October 13, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital de Clinicas de Porto Alegre</investigator_affiliation>
    <investigator_full_name>Beatriz D'Agord Schaan</investigator_full_name>
    <investigator_title>Beatriz D'Agord Schaan</investigator_title>
  </responsible_party>
  <keyword>Glycemic variability, exercise, diabetes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <!-- 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/NCT02262208
org study id: 120148
nct id: NCT02262208
lead sponsor: 
has dmc: Yes
The aim this study is characterize glycemic variability using linear and nonlinear
      mathematical tools, under basal conditions and in response to specific protocols acute
      exercise that evoke oxidative stress and inflammation in healthy subjects and type 2 diabetes
      patients. For this purpose, the sample size will consist of 37 individuals healthy and 32
      without type 2 diabetes mellitus wore a CGMS during 3 days. Participants randomly performed
      aerobic and eccentric sessions, both in the morning (24h after CGMS placement), and at least
      7 days apart. Glucose variability was evaluated by glucose standard deviation, glucose
      variance, mean amplitude of glycemic excursions (MAGE), and glucose coefficient of variation
      (conventional methods) as well as by spectral and symbolic analysis (non-conventional
      methods). Physiological mechanisms altered by exercise protocols (Human Soluble Interleukin-6
      and Glutathione), will be measured in blood samples.
The aim this study is characterize glycemic variability using linear and nonlinear
      mathematical tools, under basal conditions and in response to specific protocols acute
      exercise that evoke oxidative stress and inflammation in healthy subjects and type 2 diabetes
      patients. For this purpose, the sample size will consist of 37 individuals healthy and 32
      without type 2 diabetes mellitus, which will undertake the two types of exercise, randomly
      distributed. The maximal incremental exercise test will be performed in electrically braked
      cycle ergometer (ER-900, Jaeger, Wu¨ rzburg, Germany) in order to assess possible
      contraindications to the proposed protocol as well functional capacity, which will be used in
      prescription of the aerobic exercise session and a testing strength maximal will be conducted
      and used in the prescription of the eccentric exercise session.

      The glucose variability will be assessed by continuous glucose monitoring system (CGMS)
      during 72h. Glucose variability will be evaluated by glucose standard deviation, glucose
      variance, mean amplitude of glycemic excursions (MAGE), and glucose coefficient of variation
      (conventional methods) as well as by spectral and symbolic analysis (non-conventional
      methods). Physiological mechanisms altered by exercise protocols will be measured in blood
      samples., Human Soluble Interleukin-6 ( HU IL 6 ELISA KIT - BIOSOURCE) and Glutathione (GSH)
      indicator of oxidative stress (GSH assay in: Rahman I, Kode A, Biswas SK. Nat Protoc.
      2006;1(6):3159-65). The aerobic session will consist of 40 min of lower limb bicycle at 70%
      of the peak heart rate, as determined in the incremental exercise test and eccentric session
      will consist of 40 min of one lower -limb exercises (leg press) with 6 sets of 10 repetitions
      at 120% of 1-RM. The protocol was approved by the Ethics in Research Committee at Hospital de
      Clínicas de Porto Alegre and all patients will provide their written informed consent before
      the participation.The research will be performed at the Exercise Pathophysiology Research
      laboratory of the Hospital de Clínicas de Porto Alegre. We believe that signs of glycemic
      variability has characteristics detectable by alternative, related to hysiological processes
      such as oxidative stress and inflammation, evoked by aerobic and eccentric exercise protocols
      mathematical methods, may help explain the acute response of healthy individuals and patients
      with type 2 diabetes.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Single (Investigator)
measure: Glycemic variability by continuous glucose monitoring system
time frame: The monitor that analyzes the data every 10s and reports average values every 5 min, totalizing 288 readings per day. Glucose profiles will be collected the day before (day 1), the day of (day 2), and the day following (day 3) of 40 min of both exercise.
description: Will be assessed conventional and non-conventional methods to analyze glucose variability derived from multiple measurements performed with continuous glucose monitoring system (CGMS).Subjects will be admitted to the laboratory in the morning at approximately 9:00 a.m., 24 h before the exercise session, when the glucose sensor (Sof-SensorTM, Medtronic Mini-Med, Northridge, USA) will be inserted subcutaneously. The sensor is a glucose oxidase based platinum electrode that is inserted through a needle into the subcutaneous tissue of the anterior abdominal wall, using a spring-loaded device (Senserter, Medtronic, Northridge, USA). Glucose profiles will be collected the day before (day 1), the day of (day 2), and the day following (day 3) and 40 min of exercise. Each sensor will be used continuously for up to 72 h.
measure: Oxidative stress
time frame: 10 minutes before the exercise sessions and 10 minutes after the exercise sessions.
description: Will be assessed by Glutathione (GSH) indicator of oxidative stress (GSH assay in: Rahman I, Kode A, Biswas SK Nat PROTOC 2006, 1 (6): 3159-65.
arm group label: Patients with type 2 diabetes
arm group type: Other
arm group label: Healthy
arm group type: Other
intervention type: Other
intervention name: Aerobic Exercises
description: Exercise intensity for each individual by a heart rate monitor (Polar F1 TM, Polar Electro Oy, Helsinki, Finland), and a Borg 0-10 scale used to register individuals' perceived exertion every 5 minutes throughout the experimental sessions.
Aerobic session will consist of 40 min of lower limb bicycle at 70% of the peak heart rate, as determined in the incremental exercise test.
arm group label: Healthy
arm group label: Patients with type 2 diabetes
intervention type: Other
intervention name: Eccentric Exercise
description: Eccentric session will consist of 40 min of one lower -limb exercises (leg press) with 6 sets of 10 repetitions at 120% of 1-RM.
arm group label: Healthy
arm group label: Patients with type 2 diabetes
intervention type: Device
intervention name: Continuous glucose monitoring system (Guardian, Medtronic, Northridge, USA)
description: Subjects will be admitted to the laboratory in the morning at approximately 9:00 a.m., 24 h before the exercise session, when the glucose sensor (Sof-SensorTM, Medtronic Mini-Med, Northridge, USA) will be inserted subcutaneously. The sensor is a glucose oxidase based platinum electrode that is inserted through a needle into the subcutaneous tissue of the anterior abdominal wall, using a spring-loaded device (Senserter, Medtronic, Northridge, USA). Glucose profiles will be collected the day before (day 1), the day of (day 2), and the day following (day 3) and 40 min of exercise. Each sensor will be used continuously for up to 72 h.
arm group label: Healthy
arm group label: Patients with type 2 diabetes
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
investigator: 
country: Brazil
citation: Rahman I, Kode A, Biswas SK. Assay for quantitative determination of glutathione and glutathione disulfide levels using enzymatic recycling method. Nat Protoc. 2006;1(6):3159-65. doi: 10.1038/nprot.2006.378.
PMID: 17406579
responsible party type: Principal Investigator
investigator affiliation: Hospital de Clinicas de Porto Alegre
investigator full name: Beatriz D'Agord Schaan
investigator title: Beatriz D'Agord Schaan
mesh term: Diabetes Mellitus, Type 2