<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/NCT04443777</url>
  </required_header>
  <id_info>
    <org_study_id>5649/19</org_study_id>
    <nct_id>NCT04443777</nct_id>
  </id_info>
  <brief_title>Analysis of Ergogenic Potential and Risks Associated With Acute and Chronic Use of Sulphonylureas on Physical Exercise</brief_title>
  <official_title>Analysis of Ergogenic Potential and Risks Associated With Acute and Chronic Use of Sulphonylureas on Physical Exercise</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto de Cardiologia do Rio Grande do Sul</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto de Cardiologia do Rio Grande do Sul</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>
      This study have like aim to examine whether insulin secretagogues have a potential ergogenic&#xD;
      effect leading to a better exercise performance and post-exercise recovery in healthy&#xD;
      individuals after a resistance training session. METHODS: This is a randomized, double-blind,&#xD;
      placebo-controlled, clinical trial. The sample will consist of 44 men. Subjects will be&#xD;
      randomly allocated (block randomization, www.randomizer.org) to the following groups: placebo&#xD;
      (PFG, n=22) and sulphonylurea (GFS, n=22). The study will consist of 3 visits 7 days apart.&#xD;
      On visit 1 the participants will ask to sign an informed consent form and will carry out&#xD;
      medical evaluation with anthropometric assessment. At that visit they will perform a&#xD;
      one-repetition maximum test of the upper limbs by using the horizontal bench press and of the&#xD;
      lower limbs by using the 45º leg press. On visit 2, they will perform a second round of&#xD;
      similar 1-RM tests to determine workloads for the study session [sulphonylurea (gliclazide)&#xD;
      vs. placebo]. The experimental exercise session will be held on visits 3. Gliclazide modified&#xD;
      release 60 mg (Diamicron® MR) or placebo (starch, sodium lauryl sulfate and Aerosil) will be&#xD;
      orally administered as matched capsules (same color, flavor, smell and size) 8 hours before&#xD;
      the beginning of exercise session, double-blind. In the experimental session, first, warm-up&#xD;
      on the bench press and leg press, both with workload at 50% of 1-RM will be carried out.&#xD;
      After a 2-minute rest, the resistance training session will be started. It will consist of 4&#xD;
      sets of bench press and leg press exercises at 65% of 1-RM with maximum repetitions until&#xD;
      concentric failure. The bench press exercises will be followed by the leg press exercises&#xD;
      with no interval between them. A 2-minute interval will allowed after each series of&#xD;
      exercises. Measurements for heart rate (HR) and Visual Analogue Scale (VAS) for Pain will be&#xD;
      taken before, between each series of exercises and 24 and 48 hours after session. Venous&#xD;
      blood samples will be obtained before, immediately after, 24 and 48 hours after, for&#xD;
      determining serum levels of creatine kinase isoenzyme MM and lactate dehydrogenase. Capillary&#xD;
      blood for glucose determination will be collected from the digital pulp using a glucometer&#xD;
      before and immediately after. Resistance training volume will be calculated for each type of&#xD;
      exercise as well as total training volume for each session as a product of exercise workload&#xD;
      and number of series and repetitions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The use of performance-enhancing drugs is a major area of concern for high-performance&#xD;
      athletes because it may lead to serious health problems. It is also quite concerning that&#xD;
      these substances are also widely used without guidance among non-athletes for faster results&#xD;
      and aesthetic reasons. Several substances used for doping in sports have well-established&#xD;
      ergogenic and side effects. Studies have shown that insulin is used for its anabolic effects&#xD;
      mostly among recreational and professional weightlifters and bodybuilders. Currently, insulin&#xD;
      and its analogs are on the WADA list of prohibited substances for their anabolic effects&#xD;
      mostly in muscle tissues and side effects. However, a class of drugs known as insulin&#xD;
      secretagogues are used by some athletes to enhance performance. Few studies have examined the&#xD;
      potential effects of insulin secretagogues, especially sulfonylureas, on exercise performance&#xD;
      and post-exercise recovery among athletes as well as their potential side effects. Despite&#xD;
      insufficient data supporting the use of insulin secretagogues as ergogenic supplement well as&#xD;
      well its associated risks, these substances have been empirically used for both, acute and&#xD;
      chronic effects among professional athletes and non-athletes. Thus, the present study have&#xD;
      like aim to examine whether insulin secretagogues have a potential ergogenic effect leading&#xD;
      to a better exercise performance and post-exercise recovery in healthy individuals after a&#xD;
      resistance training session. METHODS: This is a randomized, double-blind, placebo-controlled,&#xD;
      clinical trial. The sample will consist of 44 men, young adults, healthy and experienced in&#xD;
      strength training and who meet the inclusion and exclusion criteria specified. The sample&#xD;
      calculation was determined by a pilot study conducted with 10 subjects, with strength&#xD;
      performance as the primary outcome, using drug (Gliclazide) or placebo, taking into account a&#xD;
      statistical power of 95% and a significance level of 5%. For this purpose, the GPower 3.1was&#xD;
      used. Subjects will be randomly allocated (block randomization, www.randomizer.org) to the&#xD;
      following groups: placebo (PFG, n=22) and sulphonylurea (GFS, n=22). The study will consist&#xD;
      of 3 visits 7 days apart. On visit 1 the participants will ask to sign an informed consent&#xD;
      form and will carry out medical evaluation with anthropometric assessment. At that visit they&#xD;
      will perform a one-repetition maximum test of the upper limbs by using the horizontal bench&#xD;
      press and of the lower limbs by using the 45º leg press. On visit 2, they will perform a&#xD;
      second round of similar 1-RM tests to determine workloads for the study sessions&#xD;
      [sulphonylurea (gliclazide) vs. placebo]. The experimental exercise session will be held on&#xD;
      visit 3. The participants will ask to follow a personalized food intake plan prescribed by a&#xD;
      skilled provider in the 24 hours proceeding both sessions. Gliclazide modified release (MR)&#xD;
      or placebo will be orally administered as matched capsules (same color, flavor, smell and&#xD;
      size) 8 hours before the beginning of exercise session. Gliclazide 60 mg (Diamicron® MR) or&#xD;
      placebo (starch, sodium lauryl sulfate and Aerosil) will administered double-blind. Upon&#xD;
      arrival at the study site, the participants will consum a pre-workout snack. The experimental&#xD;
      protocol will start 30 minutes later. First, warm-up on the bench press and leg press, both&#xD;
      with workload at 50% of 1-RM wil be carried out. After a 2-minute rest, the resistance&#xD;
      training session will be started. It will consist of 4 sets of bench press and leg press&#xD;
      exercises at 65% of 1-RM with maximum repetitions until concentric failure, with the&#xD;
      execution speed of 2x2. The bench press exercises will be followed by the leg press exercises&#xD;
      with no interval between them. A 2-minute interval will allowed after each series of&#xD;
      exercises. Measurements for heart rate (HR) and Visual Analogue Scale (VAS) for Pain will be&#xD;
      taken before, between each series of exercises and 24 and 48 hours after session. Venous&#xD;
      blood samples will be obtained before, immediately after, 24 and 48 hours after session for&#xD;
      determining serum levels of creatine kinase isoenzyme MM and lactate dehydrogenase using a&#xD;
      colorimetric enzymatic assay. Capillary blood for glucose determination will be collected&#xD;
      from the digital pulp using a glucometer before and immediately after session. At the end of&#xD;
      exercise session, a custom will be offered to prevent potential hypoglycemic events.&#xD;
      Resistance training volume will be calculated for each type of exercise as well as total&#xD;
      training volume for each session as a product of exercise workload and number of series and&#xD;
      repetitions. The data will be present as means ± standard deviation (SD). Repeated measures&#xD;
      ANOVA Two Way using Bonferroni post-hoc tests will be used for comparisons between the study&#xD;
      drug and placebo over time. All data analyses will be carried out using SPSS 23.0 at a&#xD;
      significance level of p&lt;0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">September 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 1, 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>
    <intervention_model_description>This is a randomized, double-blind, placebo-controlled, parallel-group clinical trial.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Resistance Training Performance</measure>
    <time_frame>one week</time_frame>
    <description>The performance of resistance training will be measured by the volume of training. This measure is obtained by the total load performed by the subject, measured in kilograms (Kg), being a product of the number of repetitions x the number of series and the load lifted by repetition (volume of training (Kg) = workload (Kg) x Repetition (nº) x Series (nº)). (18. Correa CS, Cadore EL, Martins JB, Silva ER, Pinto RS, Oliveira AR, Kruel LFM. The effects of ibuprofen on muscle performance, worload and plasma creatine kinase during strength training session. Medicina Sportiva. 2012;16(1):17-21).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Muscle Recovery Marker 1</measure>
    <time_frame>one week</time_frame>
    <description>Serum levels of creatine kinase isoenzyme MM (CK-MM)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Muscle Recovery Marker 2</measure>
    <time_frame>one week</time_frame>
    <description>Serum levels of lactate dehydrogenase (LDH)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective Perception Pain</measure>
    <time_frame>one week</time_frame>
    <description>Visual Analogue Scale (VAS) for Pain is a visual scale in which the subject reports how much pain the subject is feeling at the moment. This scale ranges from 0 to 10, where 0 means no pain and 10 means the greatest pain the subject has ever felt. It will be taken before, between each series of exercises and 24 and 48 hours after each session.The smaller the subjective sensation of pain, in this study, it will mean that recovery was faster and / or more effective.(16. Jensen M, Karoly P, Braver S. The measurement of clinical pain intensity: a comparision of six methods. Pain. 1986;27:117-26).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood Glucose Concentration</measure>
    <time_frame>one week</time_frame>
    <description>Capillary blood for blood glucose determination will be collected from the digital pulp using a glucometer (Free Style Optium) before and immediately after each session</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">44</enrollment>
  <condition>Resistance Training</condition>
  <condition>Sport Performance</condition>
  <condition>Muscle Recovery</condition>
  <condition>Hypoglycemic Agents</condition>
  <condition>Randomized Controlled Trial</condition>
  <arm_group>
    <arm_group_label>Sulphonylurea Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Gliclazide 60 mg (Diamicron® MR) will be orally administered as matched capsules (same color, flavor, smell and size) 8 hours before the beginning of exercise session.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo (starch, sodium lauryl sulfate and Aerosil) will be orally administered as matched capsules (same color, flavor, smell and size) 8 hours before the beginning of exercise session.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Resistance Training</intervention_name>
    <description>Both groups will perform the resistance training protocol that will consist of a warm-up on the bench press and leg press, both with workload at 50% of 1-RM. After a 2-minute rest, the resistance training session will be started. It will consist of 4 sets of bench press and leg press exercises at 65% of 1-RM with maximum repetitions until concentric failure, with the execution speed of 2x2. The bench press exercises will be followed by the leg press exercises with no interval between them. A 2-minute interval will allowed after each series of exercises.</description>
    <arm_group_label>Placebo Group</arm_group_label>
    <arm_group_label>Sulphonylurea Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  continuously resistance-trained for 2 years or more&#xD;
&#xD;
          -  minimum frequency of 3 weekly sessions&#xD;
&#xD;
          -  preceding 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  self-reported acute or chronic use of drugs including anabolic androgenic steroids,&#xD;
             anti-inflammatory drugs, beta-blockers and exogenous insulin for the last 12 months&#xD;
&#xD;
          -  alcohol intake within 72 hours of the study intervention&#xD;
&#xD;
          -  injuries to bones and muscles preventing physical exercise&#xD;
&#xD;
          -  non-adherence to dietary recommendations as instructed by the research team&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jocelito B Martins, MSc</last_name>
    <phone>+55 51 9999-76244</phone>
    <email>martins.jocelito@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Alexandre M Lehnen, PhD</last_name>
    <phone>+55 51 9997-68092</phone>
    <email>amlehnen@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Fundação Universitária de Cardiologia/ Instituto de Cardiologia</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <zip>90040-371</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jocelito B Martins</last_name>
      <email>martins.jocelito@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>June 20, 2020</last_update_submitted>
  <last_update_submitted_qc>June 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Instituto de Cardiologia do Rio Grande do Sul</investigator_affiliation>
    <investigator_full_name>Jocelito Bijoldo Martins</investigator_full_name>
    <investigator_title>PhD student</investigator_title>
  </responsible_party>
  <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/NCT04443777
org study id: 5649/19
nct id: NCT04443777
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study have like aim to examine whether insulin secretagogues have a potential ergogenic
      effect leading to a better exercise performance and post-exercise recovery in healthy
      individuals after a resistance training session. METHODS: This is a randomized, double-blind,
      placebo-controlled, clinical trial. The sample will consist of 44 men. Subjects will be
      randomly allocated (block randomization, www.randomizer.org) to the following groups: placebo
      (PFG, n=22) and sulphonylurea (GFS, n=22). The study will consist of 3 visits 7 days apart.
      On visit 1 the participants will ask to sign an informed consent form and will carry out
      medical evaluation with anthropometric assessment. At that visit they will perform a
      one-repetition maximum test of the upper limbs by using the horizontal bench press and of the
      lower limbs by using the 45º leg press. On visit 2, they will perform a second round of
      similar 1-RM tests to determine workloads for the study session [sulphonylurea (gliclazide)
      vs. placebo]. The experimental exercise session will be held on visits 3. Gliclazide modified
      release 60 mg (Diamicron® MR) or placebo (starch, sodium lauryl sulfate and Aerosil) will be
      orally administered as matched capsules (same color, flavor, smell and size) 8 hours before
      the beginning of exercise session, double-blind. In the experimental session, first, warm-up
      on the bench press and leg press, both with workload at 50% of 1-RM will be carried out.
      After a 2-minute rest, the resistance training session will be started. It will consist of 4
      sets of bench press and leg press exercises at 65% of 1-RM with maximum repetitions until
      concentric failure. The bench press exercises will be followed by the leg press exercises
      with no interval between them. A 2-minute interval will allowed after each series of
      exercises. Measurements for heart rate (HR) and Visual Analogue Scale (VAS) for Pain will be
      taken before, between each series of exercises and 24 and 48 hours after session. Venous
      blood samples will be obtained before, immediately after, 24 and 48 hours after, for
      determining serum levels of creatine kinase isoenzyme MM and lactate dehydrogenase. Capillary
      blood for glucose determination will be collected from the digital pulp using a glucometer
      before and immediately after. Resistance training volume will be calculated for each type of
      exercise as well as total training volume for each session as a product of exercise workload
      and number of series and repetitions.
The use of performance-enhancing drugs is a major area of concern for high-performance
      athletes because it may lead to serious health problems. It is also quite concerning that
      these substances are also widely used without guidance among non-athletes for faster results
      and aesthetic reasons. Several substances used for doping in sports have well-established
      ergogenic and side effects. Studies have shown that insulin is used for its anabolic effects
      mostly among recreational and professional weightlifters and bodybuilders. Currently, insulin
      and its analogs are on the WADA list of prohibited substances for their anabolic effects
      mostly in muscle tissues and side effects. However, a class of drugs known as insulin
      secretagogues are used by some athletes to enhance performance. Few studies have examined the
      potential effects of insulin secretagogues, especially sulfonylureas, on exercise performance
      and post-exercise recovery among athletes as well as their potential side effects. Despite
      insufficient data supporting the use of insulin secretagogues as ergogenic supplement well as
      well its associated risks, these substances have been empirically used for both, acute and
      chronic effects among professional athletes and non-athletes. Thus, the present study have
      like aim to examine whether insulin secretagogues have a potential ergogenic effect leading
      to a better exercise performance and post-exercise recovery in healthy individuals after a
      resistance training session. METHODS: This is a randomized, double-blind, placebo-controlled,
      clinical trial. The sample will consist of 44 men, young adults, healthy and experienced in
      strength training and who meet the inclusion and exclusion criteria specified. The sample
      calculation was determined by a pilot study conducted with 10 subjects, with strength
      performance as the primary outcome, using drug (Gliclazide) or placebo, taking into account a
      statistical power of 95% and a significance level of 5%. For this purpose, the GPower 3.1was
      used. Subjects will be randomly allocated (block randomization, www.randomizer.org) to the
      following groups: placebo (PFG, n=22) and sulphonylurea (GFS, n=22). The study will consist
      of 3 visits 7 days apart. On visit 1 the participants will ask to sign an informed consent
      form and will carry out medical evaluation with anthropometric assessment. At that visit they
      will perform a one-repetition maximum test of the upper limbs by using the horizontal bench
      press and of the lower limbs by using the 45º leg press. On visit 2, they will perform a
      second round of similar 1-RM tests to determine workloads for the study sessions
      [sulphonylurea (gliclazide) vs. placebo]. The experimental exercise session will be held on
      visit 3. The participants will ask to follow a personalized food intake plan prescribed by a
      skilled provider in the 24 hours proceeding both sessions. Gliclazide modified release (MR)
      or placebo will be orally administered as matched capsules (same color, flavor, smell and
      size) 8 hours before the beginning of exercise session. Gliclazide 60 mg (Diamicron® MR) or
      placebo (starch, sodium lauryl sulfate and Aerosil) will administered double-blind. Upon
      arrival at the study site, the participants will consum a pre-workout snack. The experimental
      protocol will start 30 minutes later. First, warm-up on the bench press and leg press, both
      with workload at 50% of 1-RM wil be carried out. After a 2-minute rest, the resistance
      training session will be started. It will consist of 4 sets of bench press and leg press
      exercises at 65% of 1-RM with maximum repetitions until concentric failure, with the
      execution speed of 2x2. The bench press exercises will be followed by the leg press exercises
      with no interval between them. A 2-minute interval will allowed after each series of
      exercises. Measurements for heart rate (HR) and Visual Analogue Scale (VAS) for Pain will be
      taken before, between each series of exercises and 24 and 48 hours after session. Venous
      blood samples will be obtained before, immediately after, 24 and 48 hours after session for
      determining serum levels of creatine kinase isoenzyme MM and lactate dehydrogenase using a
      colorimetric enzymatic assay. Capillary blood for glucose determination will be collected
      from the digital pulp using a glucometer before and immediately after session. At the end of
      exercise session, a custom will be offered to prevent potential hypoglycemic events.
      Resistance training volume will be calculated for each type of exercise as well as total
      training volume for each session as a product of exercise workload and number of series and
      repetitions. The data will be present as means ± standard deviation (SD). Repeated measures
      ANOVA Two Way using Bonferroni post-hoc tests will be used for comparisons between the study
      drug and placebo over time. All data analyses will be carried out using SPSS 23.0 at a
      significance level of p<0.05.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a randomized, double-blind, placebo-controlled, parallel-group clinical trial.
primary purpose: Other
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Resistance Training Performance
time frame: one week
description: The performance of resistance training will be measured by the volume of training. This measure is obtained by the total load performed by the subject, measured in kilograms (Kg), being a product of the number of repetitions x the number of series and the load lifted by repetition (volume of training (Kg) = workload (Kg) x Repetition (nº) x Series (nº)). (18. Correa CS, Cadore EL, Martins JB, Silva ER, Pinto RS, Oliveira AR, Kruel LFM. The effects of ibuprofen on muscle performance, worload and plasma creatine kinase during strength training session. Medicina Sportiva. 2012;16(1):17-21).
measure: Muscle Recovery Marker 1
time frame: one week
description: Serum levels of creatine kinase isoenzyme MM (CK-MM)
measure: Muscle Recovery Marker 2
time frame: one week
description: Serum levels of lactate dehydrogenase (LDH)
measure: Subjective Perception Pain
time frame: one week
description: Visual Analogue Scale (VAS) for Pain is a visual scale in which the subject reports how much pain the subject is feeling at the moment. This scale ranges from 0 to 10, where 0 means no pain and 10 means the greatest pain the subject has ever felt. It will be taken before, between each series of exercises and 24 and 48 hours after each session.The smaller the subjective sensation of pain, in this study, it will mean that recovery was faster and / or more effective.(16. Jensen M, Karoly P, Braver S. The measurement of clinical pain intensity: a comparision of six methods. Pain. 1986;27:117-26).
measure: Blood Glucose Concentration
time frame: one week
description: Capillary blood for blood glucose determination will be collected from the digital pulp using a glucometer (Free Style Optium) before and immediately after each session
arm group label: Sulphonylurea Group
arm group type: Active Comparator
description: Gliclazide 60 mg (Diamicron® MR) will be orally administered as matched capsules (same color, flavor, smell and size) 8 hours before the beginning of exercise session.
arm group label: Placebo Group
arm group type: Placebo Comparator
description: Placebo (starch, sodium lauryl sulfate and Aerosil) will be orally administered as matched capsules (same color, flavor, smell and size) 8 hours before the beginning of exercise session.
intervention type: Other
intervention name: Resistance Training
description: Both groups will perform the resistance training protocol that will consist of a warm-up on the bench press and leg press, both with workload at 50% of 1-RM. After a 2-minute rest, the resistance training session will be started. It will consist of 4 sets of bench press and leg press exercises at 65% of 1-RM with maximum repetitions until concentric failure, with the execution speed of 2x2. The bench press exercises will be followed by the leg press exercises with no interval between them. A 2-minute interval will allowed after each series of exercises.
arm group label: Placebo Group
arm group label: Sulphonylurea Group
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jocelito B Martins, MSc
phone: +55 51 9999-76244
email: martins.jocelito@gmail.com
last name: Alexandre M Lehnen, PhD
phone: +55 51 9997-68092
email: amlehnen@gmail.com
facility: 
status: Recruiting
contact: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Instituto de Cardiologia do Rio Grande do Sul
investigator full name: Jocelito Bijoldo Martins
investigator title: PhD student
sharing ipd: No