<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/NCT04489966</url>
  </required_header>
  <id_info>
    <org_study_id>2019LWKY009</org_study_id>
    <nct_id>NCT04489966</nct_id>
  </id_info>
  <brief_title>Effects of Aerobic Training on Pancreatic Fat and Cognitive Function in T2DM Patients</brief_title>
  <official_title>Effects of Aerobic Training on Pancreatic Fat and Cognitive Function in Patients With Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanjing University of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nanjing University of Traditional Chinese Medicine</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>
      The primary aim of this study was to evaluate the difference in cognitive function and brain&#xD;
      functional structure between exercise group and control group by performing regular one-year&#xD;
      moderate-intensity aerobic training in type 2 diabetes mellitus (T2DM) with normal cognitive&#xD;
      function. The secondary aim of this study was to explore the effects of six-month regular&#xD;
      moderate-intensity aerobic training on pancreatic fat content, metabolic index of glucose and&#xD;
      lipid, as well as cardiovascular risks in patients type 2 diabetes mellitus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In recent years, more attention has been paid to the role of aerobic exercise in improving&#xD;
      cognitive ability, but there is still a lack of prospective studies on the T2DM population&#xD;
      with normal cognitive function. Therefore, the purpose of this study is to compare the&#xD;
      differences of cognitive function and hippocampal volume between exercise group and&#xD;
      non-exercise group by regular moderate-intensity aerobic exercise intervention for one year&#xD;
      in T2DM patients with normal cognitive function to evaluate the impact of aerobic exercise on&#xD;
      cognitive function and hippocampal volume for these patients and provide scientific evidence&#xD;
      for early prevention and delaying the occurrence of cognitive dysfunction in patients with&#xD;
      T2DM. Pancreatic fat deposition in patients with type 2 diabetes is not only a simple fat&#xD;
      accumulation but also an early marker of insulin resistance. In this study, The effectiveness&#xD;
      of six months of an aerobic exercise intervention on pancreas fat reduction for type 2&#xD;
      diabetes patients was examed.&#xD;
&#xD;
      In this study, 106 T2DM patients who met the inclusion criteria were enrolled and randomized&#xD;
      into two groups. All patients received diabetes education(once a month, the course will be&#xD;
      focused on basic knowledge of diabetes, diet management, and blood glucose monitoring). The&#xD;
      control group followed their regular lifestyle without exercise intervention and recorded&#xD;
      24-hour dietary intake. The aerobic training group was supervised by the trainers who had&#xD;
      received professional training and given 60min moderate aerobic rhythmic exercise (including&#xD;
      5min warm-up, 50min aerobic exercise, and 5min stretching exercise).&#xD;
&#xD;
      Baseline assessment included demographic data, duration of diabetes, body mass index（BMI）,&#xD;
      waist circumference（WC）, hip circumference（HC）, systolic blood press（SBP）, diastolic blood&#xD;
      press（DBP）, smoking and drinking, drug use, acute and chronic complications of diabetes,&#xD;
      other chronic complications, 24-hour diet review, international physical activity&#xD;
      questionnaire (IPAQ).&#xD;
&#xD;
      Evaluation after 6 months of intervention included pancreatic fat content(PFC), liver fat&#xD;
      content (LFC), visceral adipose tissue (VAT), subcutaneous adipose tissue(SAT), fasting&#xD;
      plasma glucose (FPG), 2-hour postprandial blood glucose(2hPG), hemoglobin A1c(HbA1c), fasting&#xD;
      insulin (FINS), homeostasis model assessment of insulin resistance(HOMA2-IR), homeostasis&#xD;
      model assessment of Beta-cell function (HOMA2-β), early insulin secretion index(Δ I30 / Δ&#xD;
      G30), total cholesterol(TC),&#xD;
      triglycerides(TG),high-density-lipoprotein-cholesterol(HDL-C),low-density lipoprotein&#xD;
      cholesterol(LDL-C). The Framingham cardiovascular risk scale (Framingham) and 10-year&#xD;
      ischemic cardiovascular disease risk assessment (ICVD) scores were calculated.&#xD;
&#xD;
      Evaluation after 12 months of intervention included fasting plasma glucose(FPG),30 minutes&#xD;
      postprandial glucose(30minPG), 2-hour postprandial glucose(2hPG)，hemoglobin A1c(HbA1c),&#xD;
      fasting insulin(FINS),30 minutes Insulin(30minINS), homeostasis model assessment of insulin&#xD;
      resistance(HOMA2-IR),homeostasis model assessment of Beta cell function(HOMA2-β),early&#xD;
      insulin secretion index(Δ I30 / Δ&#xD;
      G30),totalcholesterol(TC),triglycerides(TG),high-density-lipoprotein cholesterol(&#xD;
      HDL-c），low-density-lipoprotein cholesterol(LDL-c),muscle mass, right, left hippocampal volume&#xD;
      of hippocampal volume, the hippocampal volume, and total physical activity energy&#xD;
      expenditure, total moderate physical activity energy expenditure. In addition to this,&#xD;
      cognitive function (MMSE, MoCA) were also evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Actual">March 20, 2020</completion_date>
  <primary_completion_date type="Actual">January 1, 2020</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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cognitive function scale(1)</measure>
    <time_frame>12 months</time_frame>
    <description>Mini-mental State Examination(MMSE) includes five aspects: orientation, memory, attention and calculation, recall and language ability, with a total score of 30.The scoring standard is: 27-30 is normal;&lt; 27 was divided into cognitive impairment;Mild cognitive impairment ≥21 and &lt; 27 points;Moderate cognitive impairment 10-20;Severe cognitive impairment ≤9, the higher the score, the better the cognitive function.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cognitive function scale(2)</measure>
    <time_frame>12 months</time_frame>
    <description>The Montreal Cognitive Assessment Scale (MoCA) includes eight aspects: visuospatial and executive function, nomenclature, memory, attention, language, abstraction, delayed recall, and orientation for a total of 30 points.The score criteria are as follows: ≥26 is considered as normal cognitive function; &lt; 26 is considered as cognitive dysfunction. If the number of years of education ≤12 years, the score is added 1 point to correct cultural influence. The lower the score, the worse the cognitive function.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Brain functional structure---Hippocampal volume</measure>
    <time_frame>12 months</time_frame>
    <description>Hippocampal volume measurement by the same operation, all patients using 3D brain volume sequence (3D - BRAVO) image data acquisition of high resolution T1W1 brain structure, specific scanning parameters is as follows: repetition time (TR) = 9.5 ms, Time of Echo(TE) = 3.9 ms, Flip angle (FA) = 12 °, matrix=320 x 320, scanned area (FOV) = 22 x 22 cm, depth of stratum=1.5mm, interlamellar spacing =1.5mm.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Abdominal fat Abdominal fat</measure>
    <time_frame>6 months</time_frame>
    <description>Pancreatic fat content（PFC,%）</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glycemic control(1)</measure>
    <time_frame>12 months</time_frame>
    <description>Fasting Plasma Glucose(FPG, mmol/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic control(2)</measure>
    <time_frame>Time Frame: 12 months</time_frame>
    <description>2-hour postprandial blood glucose (2hPG, mmol/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin A1c</measure>
    <time_frame>12 months</time_frame>
    <description>Hemoglobin A1c(HbA1c,mml/ml)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HOMA2-IR and HOMA2-β</measure>
    <time_frame>12 months</time_frame>
    <description>Homa-IR is an indicator used to assess an individual's level of insulin resistance, HOMA-β is used to evaluate the function of individual islet cells, ΔI30/ΔG30（The ratio of net insulin to glucose increment 30 min after glucose load）</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood lipids</measure>
    <time_frame>12 months</time_frame>
    <description>Total Cholesterol(TC,mmol/L),Triglycerides(TG,mmol/L), High-density-lipoprotein Cholesterol(HDL-c,mmol/L), Low-density-lipoprotein Cholesterol(LDL-c,mmol/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other abdominal fat(1)</measure>
    <time_frame>6 months</time_frame>
    <description>Liver fat content(LFC,%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other abdominal fat(2)</measure>
    <time_frame>6 months</time_frame>
    <description>Visceral adipose tissue(VAT,cm²)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other abdominal fat(3)</measure>
    <time_frame>6 months</time_frame>
    <description>Subcutaneous adipose tissue(SAT,cm²)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The international physical activity questionnaire</measure>
    <time_frame>6 months</time_frame>
    <description>The international physical activity questionnaire (IPAQ) content mainly includes five aspects: physical activity of the relevant related work (including high levels of physical activity, moderate physical activity, walking), traffic-related physical activity (including bus, ride a bike, on foot), housework on physical activity (courtyard in heavy physical activity, physical activity among the courtyard, indoor physical activity), entertainment and leisure-time physical activity (walking, heavy physical activity, moderate physical activity) and meditation time. Participants were asked to recall the amount of time spent in each type of activity during the past week, including the number of days during the week and the number of hours spent each day, and to assign MET values to each type of physical activity using the MTE table. Energy consumption (MEt-min /week) for each type of physical activity = metabolic value of the activity (MET) × activity time per day (min) × activity days /week</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Framingham Cardiovascular Risk Scale</measure>
    <time_frame>6 months</time_frame>
    <description>The Framingham Cardiovascular Risk Scale is used to predict 10-year cardiovascular disease severity, cardiovascular event risk, and risk stratification. The scale includes 6 risk factors, including gender, age, TC, HDL-C, SBP, and smoking status. The total score was determined according to gender, then the corresponding scores were determined according to age, TC, HDL-C, SBP, and smoking status. The total score was calculated by adding up, and then the 10-year incidence risk of CHD corresponding to the total score was looked up. 10-year cardiovascular risk of &lt; 10% is a low risk, 10-20% is a moderate risk, and &gt; 20% is a high risk.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The 10-year risk assessment table for Ischemic cardiovascular disease</measure>
    <time_frame>6 months</time_frame>
    <description>The 10-year risk assessment table for Ischemic cardiovascular disease (ICVD) in Chinese people was used to calculate the 10-year risk of ICVD. The scores of men and women were selected based on their gender, and the corresponding scores of age, systolic blood pressure, BMI, TC, smoking, and diabetes were checked in the table. Then the total score was calculated and the absolute risk of ICVD was checked according to the total score (%). The 10-year risk of ICVD is very low, 5%-10% is low, 10%-20 is moderate, 20%-40% is high, and ≥40% is very high.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">106</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Aerobic training group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The aerobic training group was performed 3 times/week for 60 minutes/session(including 5 minutes of warm-up, 50 minutes aerobic rhythmic exercise and 5 minutes to relax) for moderate(60 to 70% of participants' HRmax) aerobic rhythmic exercise. All patients received an open class, relate to diabetes health education. The intervention lasted for 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients in control group remained the original lifestyle unchanged. All patients received an open class, relate to diabetes health education.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention was aerobic rhythmic exercise, with intensive training under the guidance and supervision of a professional.The aerobic training program required participants to exercise 3 days/week for 60 minutes/session (including 5-10 minutes of warm-up and 5-10 minutes flexibility exercises). Participants were educated on aerobic exercises (aerobic dancing) with music.The intervention lasted for one year.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Compared group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group was instructed to maintain their usual habits and received no structured exercise intervention. But the form, frequency and time of movement of each participant must be recorded.Participants receive an open diabetes health education class once a month, which is taught by a specially trained diabetes nurse.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Aerobic training</intervention_name>
    <description>The intervention was aerobic rhythmic training under the guidance and supervision of a professional. The aerobic training program required participants to exercise 3 days/week for 60 minutes/session (including 5-10 minutes of warm-up and 50 minutes aerobic training and 5-10 minutes to relax). All patients received an open class, relate to diabetes health education．</description>
    <arm_group_label>Aerobic training group</arm_group_label>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosed of T2DM based on the 1999 diagnostic criteria of the WHO;&#xD;
&#xD;
          2. Had normal muscle strength; 3.18.5≤BMI≤35kg/m2;&#xD;
&#xD;
        4.Had normal cognitive function ( MMSE ≥27 points, MoCA ≥26 points) ; 5.Primary school&#xD;
        education or above ( Participants were able to fill in the scale) ; 6.Aged 60-75 years;&#xD;
        7.Had ≥5 years duration of T2DM; 8.Had no evidence of hearing or visual impairment and&#xD;
        communication difficulties; 9.Were willing to participate in the study and signed informed&#xD;
        consent voluntarily.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. With severe acute complications of diabetes;&#xD;
&#xD;
          2. Serious heart, liver and kidney dysfunction, and cardiovascular and cerebrovascular&#xD;
             diseases, such as cerebral infarction, cerebral hemorrhage, etc.;&#xD;
&#xD;
          3. Pregnant and lactating women;&#xD;
&#xD;
          4. Sleep disorders (PSQI &gt;7 points);&#xD;
&#xD;
          5. Had a family history of dementia;&#xD;
&#xD;
          6. Alcohol dependence and oral medications that affect cognitive function (such as&#xD;
             antipsychotic drugs, sedative hypnotics, etc.);&#xD;
&#xD;
          7. Contraindications for MRI, such as metal implant in the body.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Qingqing Lou, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nanjing University of Traditional Chinese Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210028</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Alberti KG, Zimmet PZ. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus provisional report of a WHO consultation. Diabet Med. 1998 Jul;15(7):539-53. doi: 10.1002/(SICI)1096-9136(199807)15:73.0.CO;2-S.</citation>
    <PMID>9686693</PMID>
  </results_reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>January 3, 2021</last_update_submitted>
  <last_update_submitted_qc>January 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nanjing University of Traditional Chinese Medicine</investigator_affiliation>
    <investigator_full_name>Lou Qingqing</investigator_full_name>
    <investigator_title>Director of Health Education Department</investigator_title>
  </responsible_party>
  <keyword>aerobic training</keyword>
  <keyword>type 2 diabetes mellitus</keyword>
  <keyword>pancreatic fat content</keyword>
  <keyword>cognitive function</keyword>
  <keyword>hippocampal volume</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>
  <!-- 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/NCT04489966
org study id: 2019LWKY009
nct id: NCT04489966
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary aim of this study was to evaluate the difference in cognitive function and brain
      functional structure between exercise group and control group by performing regular one-year
      moderate-intensity aerobic training in type 2 diabetes mellitus (T2DM) with normal cognitive
      function. The secondary aim of this study was to explore the effects of six-month regular
      moderate-intensity aerobic training on pancreatic fat content, metabolic index of glucose and
      lipid, as well as cardiovascular risks in patients type 2 diabetes mellitus.
In recent years, more attention has been paid to the role of aerobic exercise in improving
      cognitive ability, but there is still a lack of prospective studies on the T2DM population
      with normal cognitive function. Therefore, the purpose of this study is to compare the
      differences of cognitive function and hippocampal volume between exercise group and
      non-exercise group by regular moderate-intensity aerobic exercise intervention for one year
      in T2DM patients with normal cognitive function to evaluate the impact of aerobic exercise on
      cognitive function and hippocampal volume for these patients and provide scientific evidence
      for early prevention and delaying the occurrence of cognitive dysfunction in patients with
      T2DM. Pancreatic fat deposition in patients with type 2 diabetes is not only a simple fat
      accumulation but also an early marker of insulin resistance. In this study, The effectiveness
      of six months of an aerobic exercise intervention on pancreas fat reduction for type 2
      diabetes patients was examed.

      In this study, 106 T2DM patients who met the inclusion criteria were enrolled and randomized
      into two groups. All patients received diabetes education(once a month, the course will be
      focused on basic knowledge of diabetes, diet management, and blood glucose monitoring). The
      control group followed their regular lifestyle without exercise intervention and recorded
      24-hour dietary intake. The aerobic training group was supervised by the trainers who had
      received professional training and given 60min moderate aerobic rhythmic exercise (including
      5min warm-up, 50min aerobic exercise, and 5min stretching exercise).

      Baseline assessment included demographic data, duration of diabetes, body mass index（BMI）,
      waist circumference（WC）, hip circumference（HC）, systolic blood press（SBP）, diastolic blood
      press（DBP）, smoking and drinking, drug use, acute and chronic complications of diabetes,
      other chronic complications, 24-hour diet review, international physical activity
      questionnaire (IPAQ).

      Evaluation after 6 months of intervention included pancreatic fat content(PFC), liver fat
      content (LFC), visceral adipose tissue (VAT), subcutaneous adipose tissue(SAT), fasting
      plasma glucose (FPG), 2-hour postprandial blood glucose(2hPG), hemoglobin A1c(HbA1c), fasting
      insulin (FINS), homeostasis model assessment of insulin resistance(HOMA2-IR), homeostasis
      model assessment of Beta-cell function (HOMA2-β), early insulin secretion index(Δ I30 / Δ
      G30), total cholesterol(TC),
      triglycerides(TG),high-density-lipoprotein-cholesterol(HDL-C),low-density lipoprotein
      cholesterol(LDL-C). The Framingham cardiovascular risk scale (Framingham) and 10-year
      ischemic cardiovascular disease risk assessment (ICVD) scores were calculated.

      Evaluation after 12 months of intervention included fasting plasma glucose(FPG),30 minutes
      postprandial glucose(30minPG), 2-hour postprandial glucose(2hPG)，hemoglobin A1c(HbA1c),
      fasting insulin(FINS),30 minutes Insulin(30minINS), homeostasis model assessment of insulin
      resistance(HOMA2-IR),homeostasis model assessment of Beta cell function(HOMA2-β),early
      insulin secretion index(Δ I30 / Δ
      G30),totalcholesterol(TC),triglycerides(TG),high-density-lipoprotein cholesterol(
      HDL-c），low-density-lipoprotein cholesterol(LDL-c),muscle mass, right, left hippocampal volume
      of hippocampal volume, the hippocampal volume, and total physical activity energy
      expenditure, total moderate physical activity energy expenditure. In addition to this,
      cognitive function (MMSE, MoCA) were also evaluated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Cognitive function scale(1)
time frame: 12 months
description: Mini-mental State Examination(MMSE) includes five aspects: orientation, memory, attention and calculation, recall and language ability, with a total score of 30.The scoring standard is: 27-30 is normal;< 27 was divided into cognitive impairment;Mild cognitive impairment ≥21 and < 27 points;Moderate cognitive impairment 10-20;Severe cognitive impairment ≤9, the higher the score, the better the cognitive function.
measure: Cognitive function scale(2)
time frame: 12 months
description: The Montreal Cognitive Assessment Scale (MoCA) includes eight aspects: visuospatial and executive function, nomenclature, memory, attention, language, abstraction, delayed recall, and orientation for a total of 30 points.The score criteria are as follows: ≥26 is considered as normal cognitive function; < 26 is considered as cognitive dysfunction. If the number of years of education ≤12 years, the score is added 1 point to correct cultural influence. The lower the score, the worse the cognitive function.
measure: Brain functional structure---Hippocampal volume
time frame: 12 months
description: Hippocampal volume measurement by the same operation, all patients using 3D brain volume sequence (3D - BRAVO) image data acquisition of high resolution T1W1 brain structure, specific scanning parameters is as follows: repetition time (TR) = 9.5 ms, Time of Echo(TE) = 3.9 ms, Flip angle (FA) = 12 °, matrix=320 x 320, scanned area (FOV) = 22 x 22 cm, depth of stratum=1.5mm, interlamellar spacing =1.5mm.
measure: Abdominal fat Abdominal fat
time frame: 6 months
description: Pancreatic fat content（PFC,%）
measure: Glycemic control(1)
time frame: 12 months
description: Fasting Plasma Glucose(FPG, mmol/L)
measure: Glycemic control(2)
time frame: Time Frame: 12 months
description: 2-hour postprandial blood glucose (2hPG, mmol/L)
measure: Hemoglobin A1c
time frame: 12 months
description: Hemoglobin A1c(HbA1c,mml/ml)
measure: HOMA2-IR and HOMA2-β
time frame: 12 months
description: Homa-IR is an indicator used to assess an individual's level of insulin resistance, HOMA-β is used to evaluate the function of individual islet cells, ΔI30/ΔG30（The ratio of net insulin to glucose increment 30 min after glucose load）
measure: Blood lipids
time frame: 12 months
description: Total Cholesterol(TC,mmol/L),Triglycerides(TG,mmol/L), High-density-lipoprotein Cholesterol(HDL-c,mmol/L), Low-density-lipoprotein Cholesterol(LDL-c,mmol/L)
measure: Other abdominal fat(1)
time frame: 6 months
description: Liver fat content(LFC,%)
measure: Other abdominal fat(2)
time frame: 6 months
description: Visceral adipose tissue(VAT,cm²)
measure: Other abdominal fat(3)
time frame: 6 months
description: Subcutaneous adipose tissue(SAT,cm²)
measure: The international physical activity questionnaire
time frame: 6 months
description: The international physical activity questionnaire (IPAQ) content mainly includes five aspects: physical activity of the relevant related work (including high levels of physical activity, moderate physical activity, walking), traffic-related physical activity (including bus, ride a bike, on foot), housework on physical activity (courtyard in heavy physical activity, physical activity among the courtyard, indoor physical activity), entertainment and leisure-time physical activity (walking, heavy physical activity, moderate physical activity) and meditation time. Participants were asked to recall the amount of time spent in each type of activity during the past week, including the number of days during the week and the number of hours spent each day, and to assign MET values to each type of physical activity using the MTE table. Energy consumption (MEt-min /week) for each type of physical activity = metabolic value of the activity (MET) × activity time per day (min) × activity days /week
measure: The Framingham Cardiovascular Risk Scale
time frame: 6 months
description: The Framingham Cardiovascular Risk Scale is used to predict 10-year cardiovascular disease severity, cardiovascular event risk, and risk stratification. The scale includes 6 risk factors, including gender, age, TC, HDL-C, SBP, and smoking status. The total score was determined according to gender, then the corresponding scores were determined according to age, TC, HDL-C, SBP, and smoking status. The total score was calculated by adding up, and then the 10-year incidence risk of CHD corresponding to the total score was looked up. 10-year cardiovascular risk of < 10% is a low risk, 10-20% is a moderate risk, and > 20% is a high risk.
measure: The 10-year risk assessment table for Ischemic cardiovascular disease
time frame: 6 months
description: The 10-year risk assessment table for Ischemic cardiovascular disease (ICVD) in Chinese people was used to calculate the 10-year risk of ICVD. The scores of men and women were selected based on their gender, and the corresponding scores of age, systolic blood pressure, BMI, TC, smoking, and diabetes were checked in the table. Then the total score was calculated and the absolute risk of ICVD was checked according to the total score (%). The 10-year risk of ICVD is very low, 5%-10% is low, 10%-20 is moderate, 20%-40% is high, and ≥40% is very high.
arm group label: Aerobic training group
arm group type: Experimental
description: The aerobic training group was performed 3 times/week for 60 minutes/session(including 5 minutes of warm-up, 50 minutes aerobic rhythmic exercise and 5 minutes to relax) for moderate(60 to 70% of participants' HRmax) aerobic rhythmic exercise. All patients received an open class, relate to diabetes health education. The intervention lasted for 6 months.
arm group label: Control group
arm group type: No Intervention
description: Patients in control group remained the original lifestyle unchanged. All patients received an open class, relate to diabetes health education.
arm group label: Intervention group
arm group type: Experimental
description: The intervention was aerobic rhythmic exercise, with intensive training under the guidance and supervision of a professional.The aerobic training program required participants to exercise 3 days/week for 60 minutes/session (including 5-10 minutes of warm-up and 5-10 minutes flexibility exercises). Participants were educated on aerobic exercises (aerobic dancing) with music.The intervention lasted for one year.
arm group label: Compared group
arm group type: No Intervention
description: The control group was instructed to maintain their usual habits and received no structured exercise intervention. But the form, frequency and time of movement of each participant must be recorded.Participants receive an open diabetes health education class once a month, which is taught by a specially trained diabetes nurse.
intervention type: Behavioral
intervention name: Aerobic training
description: The intervention was aerobic rhythmic training under the guidance and supervision of a professional. The aerobic training program required participants to exercise 3 days/week for 60 minutes/session (including 5-10 minutes of warm-up and 50 minutes aerobic training and 5-10 minutes to relax). All patients received an open class, relate to diabetes health education．
arm group label: Aerobic training group
arm group label: Intervention group
criteria: 
gender: All
minimum age: 60 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Qingqing Lou, PhD
role: Principal Investigator
affiliation: Nanjing University of Traditional Chinese Medicine
facility: 
country: China
citation: Alberti KG, Zimmet PZ. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus provisional report of a WHO consultation. Diabet Med. 1998 Jul;15(7):539-53. doi: 10.1002/(SICI)1096-9136(199807)15:73.0.CO;2-S.
PMID: 9686693
responsible party type: Principal Investigator
investigator affiliation: Nanjing University of Traditional Chinese Medicine
investigator full name: Lou Qingqing
investigator title: Director of Health Education Department
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2