<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/NCT04427488</url>
  </required_header>
  <id_info>
    <org_study_id>merveymz</org_study_id>
    <nct_id>NCT04427488</nct_id>
  </id_info>
  <brief_title>The Effect of Exercises Performed According to Circadian Rhythm in Type 2 Diabetes</brief_title>
  <acronym>Circadian</acronym>
  <official_title>The Effect of Exercises Performed According to Circadian Rhythm in Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul Medipol University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul Medipol University Hospital</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>
      Type 2 diabetes is a metabolic disease characterized by partial insulin deficiency or insulin&#xD;
      resistance in peripheral tissue. Type 2 diabetes, which has a very high prevalence worldwide,&#xD;
      is a socially serious health problem. Exercise has beneficial effects on the glycemic&#xD;
      profile, such as decreased glycemic hemoglobin (HbA1c) level, increased maximum oxygen&#xD;
      consumption (VO2max) and improved insulin sensitivity in diabetes patients. When the&#xD;
      literature is examined, it is seen that exercise is also effective in improving metabolic&#xD;
      health. Although the metabolic benefits of exercise have been shown, there is no study of&#xD;
      which type of exercise is more beneficial in what time of day in individuals with Type 2&#xD;
      diabetes. Circadian rhythm plays an important role in clarifying this issue because the&#xD;
      circadian rhythm is impaired in the glucose metabolism of individuals with type 2&#xD;
      diabetes.The aim of this study is to investigate which exercise is more effective in which&#xD;
      time period for individuals with Type 2 diabetes&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      INTRODUCTION: Type 2 diabetes is a metabolic disease characterized by partial insulin&#xD;
      deficiency or insulin resistance in peripheral tissue. Type 2 diabetes, which has a very high&#xD;
      prevalence worldwide, is a socially serious health problem. Complications seen with the&#xD;
      disease negatively affect human health. Physical activity and regular exercise are shown in&#xD;
      the first place with pharmacological treatment and diet approaches in the treatment of Type 2&#xD;
      diabetes. Exercise has beneficial effects on the glycemic profile, such as decreased glycemic&#xD;
      hemoglobin (HbA1c) level, increased maximum oxygen consumption (VO2max) and improved insulin&#xD;
      sensitivity in diabetes patients. When the literature is examined, it is seen that exercise&#xD;
      is also effective in improving metabolic health. Although the metabolic benefits of exercise&#xD;
      have been shown, there is no study of which type of exercise is more beneficial in what time&#xD;
      of day in individuals with Type 2 diabetes. Circadian rhythm plays an important role in&#xD;
      clarifying this issue because the circadian rhythm is impaired in the glucose metabolism of&#xD;
      individuals with type 2 diabetes.&#xD;
&#xD;
      AIM: The aim of this study is to evaluate the effectiveness of structured exercises given in&#xD;
      accordance with the circadian rhythm of individuals with type 2 diabetes.&#xD;
&#xD;
      METHOD: 30 people with Type 2 diabetes in accordance with the criteria for inclusion in the&#xD;
      Department of Endocrine and Metabolism Diseases of Medipol University Hospital in Istanbul&#xD;
      will be included in this study. Individuals who have been diagnosed with Type 2 diabetes&#xD;
      between the ages of 35-65, who have body mass index between 25 and 30, who have HbA1c value&gt;&#xD;
      6.5%, who have fasting blood glucose&gt;126 mg/dl, who have Type 2 diabetes between 5-10 years,&#xD;
      who have inactive physical activity, who independently can walk and volunteer to exercise for&#xD;
      at least 3 days a week will be included in our study. Type 1 diabetes individuals, diagnosed&#xD;
      with Latent Autoimmune Diabetes in Adults (LADA), having diabetic Ketoacidosis coma,&#xD;
      orthopedic or surgical problems to prevent walking and exercising, foot ulcers, individuals&#xD;
      have any neurologıcal problem and individuals with cardiac, pulmonary or systematic diseases&#xD;
      that will cause contraindications will not be included in the study. Blood sample&#xD;
      evaluations, circadian rhythm evaluation, 6-minute walking test, 30-second sit to stand test,&#xD;
      quality of life assessment with Ferrans&amp;Powers Quality of Life Index of the individuals&#xD;
      included will be carried out at the beginning of the study (T0) and at 6 (T1), 12 (T2) and 18&#xD;
      (T3) weeks after the study started Participants will be divided into two groups, morning (MC)&#xD;
      and evening chronotypes (EC), according to their circadian rhythms. In both groups, there was&#xD;
      a 6-week control period in which the participants continued to their routine treatment and&#xD;
      did not perform any specific exercises. In the MC group, exercises were applied in the&#xD;
      morning hours for the first 6 weeks and in the evening hours for the next 6 weeks. The EC&#xD;
      exercises were applied in the evening hours for the first 6 weeks and in the morning hours&#xD;
      for the next 6 weeks. A structured exercise program with aerobic and strengthening exercises&#xD;
      was carried out in both groups for 3 days a week over 12 weeks. . Individuals were evaluated&#xD;
      in terms of the blood test, functional capacity and quality of life at the baseline, 6 weeks&#xD;
      before the exercise, 6 and 12 weeks after the exercises.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2020</start_date>
  <completion_date type="Actual">October 15, 2021</completion_date>
  <primary_completion_date type="Actual">August 15, 2021</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HbA1c evaluation</measure>
    <time_frame>3 hours</time_frame>
    <description>Blood sample scores are changeable</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fasting glucose evaluation</measure>
    <time_frame>3 hours</time_frame>
    <description>Blood sample are changeable</description>
  </primary_outcome>
  <primary_outcome>
    <measure>HDL (high density lipoprotein) evaluation</measure>
    <time_frame>3 hours</time_frame>
    <description>Blood sample are changeable</description>
  </primary_outcome>
  <primary_outcome>
    <measure>LDL (low density lipoprotein) evaluation</measure>
    <time_frame>3 hours</time_frame>
    <description>Blood sample are changeable</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total cholesterol evaluation</measure>
    <time_frame>3 hours</time_frame>
    <description>Blood sample are changeable</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Circadian Rhythm Evaluation with Morningness Eveningness Questionnaire</measure>
    <time_frame>10 minutes</time_frame>
    <description>Scores can range from 16-86. Scores of 41 and below indicate &quot;evening types&quot;. Scores of 59 and above indicate &quot;morning types&quot;. Scores between 42 and 58 indicate &quot;intermediate types&quot; in Morningness Eveningness Questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>6-minute walking test</measure>
    <time_frame>10 minutes</time_frame>
    <description>An increase in the distance walked indicates improvement in basic mobility.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30-second sit to stand test</measure>
    <time_frame>10 minutes</time_frame>
    <description>The wide variety of ability levels indicates with high scores</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ferrans&amp;Powers Quality of Life</measure>
    <time_frame>10 minutes</time_frame>
    <description>High scores indicates high Quality of life in individuals with diabetes</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Morning Chronotype (MC) Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the MC group, exercises were applied in the morning hours for the first 6 weeks and in the evening hours for the next 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Evening Chronotype (EC) Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The EC exercises were applied in the evening hours for the first 6 weeks and in the morning hours for the next 6 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Morning Chronotype group</intervention_name>
    <description>Total of 12 weeks aerobic and strengthening exercises in different timing of the day.</description>
    <arm_group_label>Morning Chronotype (MC) Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Evening Chronotype group</intervention_name>
    <description>Total of 12 weeks aerobic and strengthening exercises in different timing of the day.</description>
    <arm_group_label>Evening Chronotype (EC) Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of Type 2 diabetes&#xD;
&#xD;
          -  Between the ages of 35-65&#xD;
&#xD;
          -  Body mass index between 25 and 30&#xD;
&#xD;
          -  HbA1c value&gt; 6.5%&#xD;
&#xD;
          -  Fasting blood glucose&gt;126 mg/dl&#xD;
&#xD;
          -  Inactive physical activity level&#xD;
&#xD;
          -  Who independently can walk and volunteer to exercise for at least 3 days a week&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of Type 1 diabetes&#xD;
&#xD;
          -  Clinical diagnosis of Latent Autoimmune Diabetes in Adults (LADA)&#xD;
&#xD;
          -  Having diabetic Ketoacidosis coma&#xD;
&#xD;
          -  Orthopedic or surgical problems to prevent walking and exercising&#xD;
&#xD;
          -  Foot ulcers&#xD;
&#xD;
          -  Neurologıcal, cardiac, pulmonary or systematic diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Istanbul Medipol University</name>
      <address>
        <city>Istanbul</city>
        <zip>34820</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_reference>
    <citation>Savikj M, Gabriel BM, Alm PS, Smith J, Caidahl K, Bjornholm M, Fritz T, Krook A, Zierath JR, Wallberg-Henriksson H. Afternoon exercise is more efficacious than morning exercise at improving blood glucose levels in individuals with type 2 diabetes: a randomised crossover trial. Diabetologia. 2019 Feb;62(2):233-237. doi: 10.1007/s00125-018-4767-z. Epub 2018 Nov 13.</citation>
    <PMID>30426166</PMID>
  </results_reference>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>December 30, 2021</last_update_submitted>
  <last_update_submitted_qc>December 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul Medipol University Hospital</investigator_affiliation>
    <investigator_full_name>merve yilmaz menek</investigator_full_name>
    <investigator_title>Lecturer</investigator_title>
  </responsible_party>
  <keyword>Circadian Rhthym</keyword>
  <keyword>Exercise</keyword>
  <keyword>Type 2 Diabetes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>An article will be published at the end of this study. IIPD can be accessed with this article.</ipd_description>
  </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/NCT04427488
org study id: merveymz
nct id: NCT04427488
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Type 2 diabetes is a metabolic disease characterized by partial insulin deficiency or insulin
      resistance in peripheral tissue. Type 2 diabetes, which has a very high prevalence worldwide,
      is a socially serious health problem. Exercise has beneficial effects on the glycemic
      profile, such as decreased glycemic hemoglobin (HbA1c) level, increased maximum oxygen
      consumption (VO2max) and improved insulin sensitivity in diabetes patients. When the
      literature is examined, it is seen that exercise is also effective in improving metabolic
      health. Although the metabolic benefits of exercise have been shown, there is no study of
      which type of exercise is more beneficial in what time of day in individuals with Type 2
      diabetes. Circadian rhythm plays an important role in clarifying this issue because the
      circadian rhythm is impaired in the glucose metabolism of individuals with type 2
      diabetes.The aim of this study is to investigate which exercise is more effective in which
      time period for individuals with Type 2 diabetes
INTRODUCTION: Type 2 diabetes is a metabolic disease characterized by partial insulin
      deficiency or insulin resistance in peripheral tissue. Type 2 diabetes, which has a very high
      prevalence worldwide, is a socially serious health problem. Complications seen with the
      disease negatively affect human health. Physical activity and regular exercise are shown in
      the first place with pharmacological treatment and diet approaches in the treatment of Type 2
      diabetes. Exercise has beneficial effects on the glycemic profile, such as decreased glycemic
      hemoglobin (HbA1c) level, increased maximum oxygen consumption (VO2max) and improved insulin
      sensitivity in diabetes patients. When the literature is examined, it is seen that exercise
      is also effective in improving metabolic health. Although the metabolic benefits of exercise
      have been shown, there is no study of which type of exercise is more beneficial in what time
      of day in individuals with Type 2 diabetes. Circadian rhythm plays an important role in
      clarifying this issue because the circadian rhythm is impaired in the glucose metabolism of
      individuals with type 2 diabetes.

      AIM: The aim of this study is to evaluate the effectiveness of structured exercises given in
      accordance with the circadian rhythm of individuals with type 2 diabetes.

      METHOD: 30 people with Type 2 diabetes in accordance with the criteria for inclusion in the
      Department of Endocrine and Metabolism Diseases of Medipol University Hospital in Istanbul
      will be included in this study. Individuals who have been diagnosed with Type 2 diabetes
      between the ages of 35-65, who have body mass index between 25 and 30, who have HbA1c value>
      6.5%, who have fasting blood glucose>126 mg/dl, who have Type 2 diabetes between 5-10 years,
      who have inactive physical activity, who independently can walk and volunteer to exercise for
      at least 3 days a week will be included in our study. Type 1 diabetes individuals, diagnosed
      with Latent Autoimmune Diabetes in Adults (LADA), having diabetic Ketoacidosis coma,
      orthopedic or surgical problems to prevent walking and exercising, foot ulcers, individuals
      have any neurologıcal problem and individuals with cardiac, pulmonary or systematic diseases
      that will cause contraindications will not be included in the study. Blood sample
      evaluations, circadian rhythm evaluation, 6-minute walking test, 30-second sit to stand test,
      quality of life assessment with Ferrans&Powers Quality of Life Index of the individuals
      included will be carried out at the beginning of the study (T0) and at 6 (T1), 12 (T2) and 18
      (T3) weeks after the study started Participants will be divided into two groups, morning (MC)
      and evening chronotypes (EC), according to their circadian rhythms. In both groups, there was
      a 6-week control period in which the participants continued to their routine treatment and
      did not perform any specific exercises. In the MC group, exercises were applied in the
      morning hours for the first 6 weeks and in the evening hours for the next 6 weeks. The EC
      exercises were applied in the evening hours for the first 6 weeks and in the morning hours
      for the next 6 weeks. A structured exercise program with aerobic and strengthening exercises
      was carried out in both groups for 3 days a week over 12 weeks. . Individuals were evaluated
      in terms of the blood test, functional capacity and quality of life at the baseline, 6 weeks
      before the exercise, 6 and 12 weeks after the exercises.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: HbA1c evaluation
time frame: 3 hours
description: Blood sample scores are changeable
measure: Fasting glucose evaluation
time frame: 3 hours
description: Blood sample are changeable
measure: HDL (high density lipoprotein) evaluation
time frame: 3 hours
description: Blood sample are changeable
measure: LDL (low density lipoprotein) evaluation
time frame: 3 hours
description: Blood sample are changeable
measure: Total cholesterol evaluation
time frame: 3 hours
description: Blood sample are changeable
measure: Circadian Rhythm Evaluation with Morningness Eveningness Questionnaire
time frame: 10 minutes
description: Scores can range from 16-86. Scores of 41 and below indicate "evening types". Scores of 59 and above indicate "morning types". Scores between 42 and 58 indicate "intermediate types" in Morningness Eveningness Questionnaire
measure: 6-minute walking test
time frame: 10 minutes
description: An increase in the distance walked indicates improvement in basic mobility.
measure: 30-second sit to stand test
time frame: 10 minutes
description: The wide variety of ability levels indicates with high scores
measure: Ferrans&Powers Quality of Life
time frame: 10 minutes
description: High scores indicates high Quality of life in individuals with diabetes
arm group label: Morning Chronotype (MC) Group
arm group type: Experimental
description: In the MC group, exercises were applied in the morning hours for the first 6 weeks and in the evening hours for the next 6 weeks.
arm group label: Evening Chronotype (EC) Group
arm group type: Experimental
description: The EC exercises were applied in the evening hours for the first 6 weeks and in the morning hours for the next 6 weeks
intervention type: Other
intervention name: Morning Chronotype group
description: Total of 12 weeks aerobic and strengthening exercises in different timing of the day.
arm group label: Morning Chronotype (MC) Group
intervention type: Other
intervention name: Evening Chronotype group
description: Total of 12 weeks aerobic and strengthening exercises in different timing of the day.
arm group label: Evening Chronotype (EC) Group
criteria: 
gender: All
minimum age: 35 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Turkey
citation: Savikj M, Gabriel BM, Alm PS, Smith J, Caidahl K, Bjornholm M, Fritz T, Krook A, Zierath JR, Wallberg-Henriksson H. Afternoon exercise is more efficacious than morning exercise at improving blood glucose levels in individuals with type 2 diabetes: a randomised crossover trial. Diabetologia. 2019 Feb;62(2):233-237. doi: 10.1007/s00125-018-4767-z. Epub 2018 Nov 13.
PMID: 30426166
responsible party type: Principal Investigator
investigator affiliation: Istanbul Medipol University Hospital
investigator full name: merve yilmaz menek
investigator title: Lecturer
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No
ipd description: An article will be published at the end of this study. IIPD can be accessed with this article.