<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/NCT03839667</url>
  </required_header>
  <id_info>
    <org_study_id>Ruijin-2018-174-2</org_study_id>
    <nct_id>NCT03839667</nct_id>
  </id_info>
  <brief_title>Intensive Diet and Physical Activity on Diabetes</brief_title>
  <acronym>IDEATE</acronym>
  <official_title>Effect of Intermittent Intensive Diet Intervention and Enhanced Physical Activity on Glycemic Control in Patients With Newly Diagnosed Type 2 diabEtes (IDEATE)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Jiao Tong University School of 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>
      It is a multicenter, open-label, parallel-group, randomized controlled clinical trial, which&#xD;
      is designed to enroll newly diagnosed type 2 diabetes patients with overweight or obesity.&#xD;
      The patients are randomized to an intensive diet intervention (intermittent very-low -calorie&#xD;
      diet), enhanced physical activity intervention (high-intensity interval training exercise&#xD;
      prescription combined with resistance training) or standard education group (diabetes health&#xD;
      education only, including lifestyle education and guidance) for 12 weeks. This trial will&#xD;
      test the primary hypothesis of whether an intensive lifestyle treatment (diet or physical&#xD;
      activity) is more effective than a standard education in glycemic control. The secondary&#xD;
      hypotheses are to compare the intensive lifestyle treatment with a standard education on&#xD;
      adipose distribution, metabolic parameters, metabolic molecules, Framingham Risk Scores, and&#xD;
      quality of life, et al.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The trial will recruit 324 patients from 2-3 hospitals within the China Diabetes Clinical&#xD;
      Research Network. Eligible criteria include men and women aged 40-70 years; newly-diagnosed&#xD;
      type 2 diabetes mellitus; BMI ≥25 kg/m2 and &lt;40 kg/m2. Main exclusion criteria include known&#xD;
      type 1 diabetes, usage of insulin; symptomatic cardiovascular diseases, and other serious&#xD;
      illness. The proposed trial has 90% statistical power to detect an absolute 0.5% reduction of&#xD;
      HbA1c changes between intensive intervention and standard education groups at a 2-sided&#xD;
      significance level of 0.05. To achieve the proposed study objectives, we plan to perform the&#xD;
      following specific aims:&#xD;
&#xD;
        1. Recruit 324 study participants who meet the eligibility criteria and randomly assign 108&#xD;
           to the intensive diet intervention group, 108 to the enhanced physical activity&#xD;
           intervention group and 108 to the standard education group for 12 weeks;&#xD;
&#xD;
        2. Employ a study-wide strategy to encourage standard of care for all participants for the&#xD;
           treatment of type 2 diabetes and other metabolic disorders;&#xD;
&#xD;
        3. Obtain clinical data on study outcomes for up to 12 months of follow-up among all trial&#xD;
           participants;&#xD;
&#xD;
        4. Perform strict quality control procedures for intervention and data collection;&#xD;
&#xD;
        5. Conduct data analysis according to the intention-to-treat principle;&#xD;
&#xD;
        6. Disseminate the study findings to influence clinical practice and clinical guidelines.&#xD;
&#xD;
      The results will be analyzed to examine the pan-omics changes after the interventions and&#xD;
      clarify their predictive benefits on the effects of the interventions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 7, 2019</start_date>
  <completion_date type="Actual">March 21, 2022</completion_date>
  <primary_completion_date type="Actual">June 17, 2021</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in HbA1C level (%)</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in HbA1C level (%)</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>proportion of reversal of diabetes</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>reduction in the dosage of hypoglycemic drugs</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in insulin sensitivity</measure>
    <time_frame>1 year</time_frame>
    <description>Quantify by HOMA score, which is calculated multiplying fasting plasma insulin (FPI, mIU/L) by fasting plasma glucose (FPG, mmol/L), then dividing by the constant 22.5, i.e. HOMA-IR = (FPI×FPG)/22.5.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in islet β-cell function</measure>
    <time_frame>1 year</time_frame>
    <description>Quantify by HOMA score, which is calculated with fasting plasma insulin (FPI, mIU/L) and fasting plasma glucose (FPG, mmol/L), i.e. HOMA-β = 20*FPI/(FPG-3.5).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in liver steatosis quantified by MRI-PDFF (percentage)</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in body mass index (BMI)</measure>
    <time_frame>1 year</time_frame>
    <description>Body weight (kg) and height (m) will be combined to report BMI in kg/m^2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in visceral fat (cm^2)</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in serum fetuin-A concentration (μg/mL)</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in serum GREM2 concentration (pg/ml)</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in serum Caspase-cleaved Keratin 1 concentration (U/L)</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in serum FGF21 concentration (pg/ml)</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in overall gut microbiota profile</measure>
    <time_frame>1 year</time_frame>
    <description>change in gut microbiota composition and proportion of specific gut flora.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>depression</measure>
    <time_frame>1 year</time_frame>
    <description>Evaluated with PHQ-9 scores. The PHQ is 59-question instrument, referring to the level of interest in doing things, feeling down or depressed, difficulty with sleeping, energy levels, eating habits, self-perception, ability to concentrate, speed of functioning and thoughts of suicide. Responses range from &quot;0&quot; (Not at all) to &quot;3&quot; (nearly every day).The total sum of the responses suggests varying levels of depression. Scores range from 0 to 27. In general, a total of 10 or above is suggestive of the presence of depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>health related quality of life</measure>
    <time_frame>1 year</time_frame>
    <description>Evaluated with HQoL scales such as Short Form 12 Health Survey Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cardiovascular risk</measure>
    <time_frame>1 year</time_frame>
    <description>Evaluated with Framingham Risk Scores. Individuals with low risk have 10% or less CHD risk at 10 years, with intermediate risk 10-20%, and with high risk 20% or more.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">326</enrollment>
  <condition>Type2 Diabetes</condition>
  <condition>Life Style</condition>
  <arm_group>
    <arm_group_label>intensive diet intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants will be instructed to restrict the total daily calorie intake to 800 kcal by receiving the very-low-calorie meal replacement formula for 2 consecutive days per week. They will be allowed to maintain their normal diet in the remaining 5 days, but need to restrict total intake to 2000 kcal per day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enhanced physical activity group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the participants will take high-intensity exercise in accordance with High Intensity Interval Training (HIIT) prescriptions, with maximum heart rate and relative maximal oxygen uptake monitored. They will take both aerobic and resistance training exercise consecutively, and total training time will be expected to reach at least 150 minutes per week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard education group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the participants will receive no extra intervention but diabetes health education, which will be carried out in large classrooms, in groups, and over the telephone. The education is mainly consisted of instructions on healthy diet and exercise plans, prevention for acute and chronic complications and self-glycemic monitoring.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>intensive diet intervention</intervention_name>
    <description>the participants will be instructed to restrict the total daily calorie intake to 800 kcal by receiving the very-low-calorie meal replacement formula for 2 consecutive days per week. They will be allowed to maintain their normal diet in the remaining 5 days, but need to restrict total intake to 2000 kcal per day.</description>
    <arm_group_label>intensive diet intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Enhanced physical activity intervention</intervention_name>
    <description>the participants will take high-intensity exercise in accordance with High Intensity Interval Training (HIIT) prescriptions, with maximum heart rate and relative maximal oxygen uptake monitored. They will take both aerobic and resistance training exercise consecutively, and total training time will be expected to reach at least 150 minutes per week.</description>
    <arm_group_label>Enhanced physical activity group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard education</intervention_name>
    <description>the participants will receive no extra intervention but diabetes health education, which will be carried out in large classrooms, in groups, and over the telephone. The education is mainly consisted of instructions on healthy diet and exercise plans, prevention for acute and chronic complications and self-glycemic monitoring.</description>
    <arm_group_label>Standard education group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Men and women aged 40-70 years;&#xD;
&#xD;
          2. Newly diagnosed type 2 diabetes&#xD;
&#xD;
               -  Duration of type 2 diabetes ≤ 2 years;&#xD;
&#xD;
               -  Antidiabetic treatment maintained for at least 6 weeks before recruitment;&#xD;
&#xD;
          3. 7.0%≤ HbA1c &lt; 9.0%;&#xD;
&#xD;
          4. 25 Kg/m2 ≤ Body mass index (BMI) &lt;40 Kg/m2;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History consistent with type 1 diabetes;&#xD;
&#xD;
          2. Insulin treatment;&#xD;
&#xD;
          3. Severe cardiovascular disease:&#xD;
&#xD;
               -  current angina&#xD;
&#xD;
               -  myocardial infarction within last six months&#xD;
&#xD;
               -  heart failure&#xD;
&#xD;
               -  symptomatic periphery vascular disease&#xD;
&#xD;
          4. Uncontrolled hypertension: systolic blood pressure &gt; 180 mmHg or diastolic blood&#xD;
             pressure &gt; 100 mmHg;&#xD;
&#xD;
          5. Myocardial ischemia indicated by resting ECG;&#xD;
&#xD;
          6. Foot ulcers, peripheral neuropathy or skeletal disorders;&#xD;
&#xD;
          7. Taking high intensity exercise more than 75 minutes or moderate intensity exercise&#xD;
             more than 150 minutes per week during the screening phase&#xD;
&#xD;
          8. Average weekly alcohol intake &gt;140 grams for men and &gt;70 grams for women;&#xD;
&#xD;
          9. ALT or AST levels more than twice the upper limit of the normal range or active liver&#xD;
             diseases;&#xD;
&#xD;
         10. eGFR &lt;60 ml/min/1.73 m2, or serum creatinine &gt;1.5 mg/dl for men or 1.3mg/dl for women;&#xD;
             or Proteinuria&#xD;
&#xD;
         11. Malignant tumor in active-stage, or in remission stage but less than 5 years from the&#xD;
             most recent treatment&#xD;
&#xD;
         12. Hemoglobin concentration &lt;130 g/l for men or &lt;120 g/l for women;&#xD;
&#xD;
         13. Past or present confirmed psychiatric illness or drug dependence;&#xD;
&#xD;
         14. History of food allergies;&#xD;
&#xD;
         15. Surgical history of digestive system;&#xD;
&#xD;
         16. Currently taking medications known to affect weight (e.g. anti thyroid drugs,&#xD;
             glucocorticoids);&#xD;
&#xD;
         17. Known to have weight-affecting diseases (e.g. malabsorption, functional bowel disease,&#xD;
             uncontrolled low sodium/hyperthyroidism, eating disorders);&#xD;
&#xD;
         18. Known to have metabolism-affecting diseases;&#xD;
&#xD;
         19. Known to have infectious diseases within last month;&#xD;
&#xD;
         20. Possible consumption of food or drugs affecting glucose homeostasis or gut microbiota&#xD;
             within the last three months;&#xD;
&#xD;
         21. Other acute diseases supported by clinical evidence which may contradict to the&#xD;
             interventions;&#xD;
&#xD;
         22. Pregnancy, currently trying to become pregnant, or of child-bearing potential and not&#xD;
             using birth control;&#xD;
&#xD;
         23. Currently participating in another intervention study;&#xD;
&#xD;
         24. Failure to obtain informed consent from participant;&#xD;
&#xD;
         25. Any factors judged by the clinic team to be likely to limit adherence to&#xD;
             interventions;&#xD;
&#xD;
         26. Any other medical condition judged by the clinic team not eligible for the trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guang Ning, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Jiao Tong University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ruijin hospital, Shanghai Jiaotong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200025</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>January 6, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>December 22, 2022</last_update_submitted>
  <last_update_submitted_qc>December 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Jiao Tong University School of Medicine</investigator_affiliation>
    <investigator_full_name>Guang Ning</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <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>Undecided</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/NCT03839667
org study id: Ruijin-2018-174-2
nct id: NCT03839667
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
It is a multicenter, open-label, parallel-group, randomized controlled clinical trial, which
      is designed to enroll newly diagnosed type 2 diabetes patients with overweight or obesity.
      The patients are randomized to an intensive diet intervention (intermittent very-low -calorie
      diet), enhanced physical activity intervention (high-intensity interval training exercise
      prescription combined with resistance training) or standard education group (diabetes health
      education only, including lifestyle education and guidance) for 12 weeks. This trial will
      test the primary hypothesis of whether an intensive lifestyle treatment (diet or physical
      activity) is more effective than a standard education in glycemic control. The secondary
      hypotheses are to compare the intensive lifestyle treatment with a standard education on
      adipose distribution, metabolic parameters, metabolic molecules, Framingham Risk Scores, and
      quality of life, et al.
The trial will recruit 324 patients from 2-3 hospitals within the China Diabetes Clinical
      Research Network. Eligible criteria include men and women aged 40-70 years; newly-diagnosed
      type 2 diabetes mellitus; BMI ≥25 kg/m2 and <40 kg/m2. Main exclusion criteria include known
      type 1 diabetes, usage of insulin; symptomatic cardiovascular diseases, and other serious
      illness. The proposed trial has 90% statistical power to detect an absolute 0.5% reduction of
      HbA1c changes between intensive intervention and standard education groups at a 2-sided
      significance level of 0.05. To achieve the proposed study objectives, we plan to perform the
      following specific aims:

        1. Recruit 324 study participants who meet the eligibility criteria and randomly assign 108
           to the intensive diet intervention group, 108 to the enhanced physical activity
           intervention group and 108 to the standard education group for 12 weeks;

        2. Employ a study-wide strategy to encourage standard of care for all participants for the
           treatment of type 2 diabetes and other metabolic disorders;

        3. Obtain clinical data on study outcomes for up to 12 months of follow-up among all trial
           participants;

        4. Perform strict quality control procedures for intervention and data collection;

        5. Conduct data analysis according to the intention-to-treat principle;

        6. Disseminate the study findings to influence clinical practice and clinical guidelines.

      The results will be analyzed to examine the pan-omics changes after the interventions and
      clarify their predictive benefits on the effects of the interventions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: change in HbA1C level (%)
time frame: 12 weeks
measure: change in HbA1C level (%)
time frame: 1 year
measure: proportion of reversal of diabetes
time frame: 1 year
measure: reduction in the dosage of hypoglycemic drugs
time frame: 1 year
measure: change in insulin sensitivity
time frame: 1 year
description: Quantify by HOMA score, which is calculated multiplying fasting plasma insulin (FPI, mIU/L) by fasting plasma glucose (FPG, mmol/L), then dividing by the constant 22.5, i.e. HOMA-IR = (FPI×FPG)/22.5.
measure: change in islet β-cell function
time frame: 1 year
description: Quantify by HOMA score, which is calculated with fasting plasma insulin (FPI, mIU/L) and fasting plasma glucose (FPG, mmol/L), i.e. HOMA-β = 20*FPI/(FPG-3.5).
measure: change in liver steatosis quantified by MRI-PDFF (percentage)
time frame: 1 year
measure: change in body mass index (BMI)
time frame: 1 year
description: Body weight (kg) and height (m) will be combined to report BMI in kg/m^2
measure: change in visceral fat (cm^2)
time frame: 1 year
measure: change in serum fetuin-A concentration (μg/mL)
time frame: 1 year
measure: change in serum GREM2 concentration (pg/ml)
time frame: 1 year
measure: change in serum Caspase-cleaved Keratin 1 concentration (U/L)
time frame: 1 year
measure: changes in serum FGF21 concentration (pg/ml)
time frame: 1 year
measure: changes in overall gut microbiota profile
time frame: 1 year
description: change in gut microbiota composition and proportion of specific gut flora.
measure: depression
time frame: 1 year
description: Evaluated with PHQ-9 scores. The PHQ is 59-question instrument, referring to the level of interest in doing things, feeling down or depressed, difficulty with sleeping, energy levels, eating habits, self-perception, ability to concentrate, speed of functioning and thoughts of suicide. Responses range from "0" (Not at all) to "3" (nearly every day).The total sum of the responses suggests varying levels of depression. Scores range from 0 to 27. In general, a total of 10 or above is suggestive of the presence of depression.
measure: health related quality of life
time frame: 1 year
description: Evaluated with HQoL scales such as Short Form 12 Health Survey Questionnaire
measure: cardiovascular risk
time frame: 1 year
description: Evaluated with Framingham Risk Scores. Individuals with low risk have 10% or less CHD risk at 10 years, with intermediate risk 10-20%, and with high risk 20% or more.
arm group label: intensive diet intervention group
arm group type: Experimental
description: The participants will be instructed to restrict the total daily calorie intake to 800 kcal by receiving the very-low-calorie meal replacement formula for 2 consecutive days per week. They will be allowed to maintain their normal diet in the remaining 5 days, but need to restrict total intake to 2000 kcal per day.
arm group label: Enhanced physical activity group
arm group type: Experimental
description: the participants will take high-intensity exercise in accordance with High Intensity Interval Training (HIIT) prescriptions, with maximum heart rate and relative maximal oxygen uptake monitored. They will take both aerobic and resistance training exercise consecutively, and total training time will be expected to reach at least 150 minutes per week.
arm group label: Standard education group
arm group type: Experimental
description: the participants will receive no extra intervention but diabetes health education, which will be carried out in large classrooms, in groups, and over the telephone. The education is mainly consisted of instructions on healthy diet and exercise plans, prevention for acute and chronic complications and self-glycemic monitoring.
intervention type: Behavioral
intervention name: intensive diet intervention
description: the participants will be instructed to restrict the total daily calorie intake to 800 kcal by receiving the very-low-calorie meal replacement formula for 2 consecutive days per week. They will be allowed to maintain their normal diet in the remaining 5 days, but need to restrict total intake to 2000 kcal per day.
arm group label: intensive diet intervention group
intervention type: Behavioral
intervention name: Enhanced physical activity intervention
description: the participants will take high-intensity exercise in accordance with High Intensity Interval Training (HIIT) prescriptions, with maximum heart rate and relative maximal oxygen uptake monitored. They will take both aerobic and resistance training exercise consecutively, and total training time will be expected to reach at least 150 minutes per week.
arm group label: Enhanced physical activity group
intervention type: Behavioral
intervention name: Standard education
description: the participants will receive no extra intervention but diabetes health education, which will be carried out in large classrooms, in groups, and over the telephone. The education is mainly consisted of instructions on healthy diet and exercise plans, prevention for acute and chronic complications and self-glycemic monitoring.
arm group label: Standard education group
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: No
last name: Guang Ning, MD, PhD
role: Principal Investigator
affiliation: Shanghai Jiao Tong University School of Medicine
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shanghai Jiao Tong University School of Medicine
investigator full name: Guang Ning
investigator title: Professor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: Undecided