<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/NCT03827382</url>
  </required_header>
  <id_info>
    <org_study_id>2018-01920</org_study_id>
    <nct_id>NCT03827382</nct_id>
  </id_info>
  <brief_title>Bicycle Exercise and Lifestyle Intervention in Newly Diagnosed Diabetes</brief_title>
  <acronym>BELIFE</acronym>
  <official_title>Bicycle Exercise and Lifestyle Intervention in Newly Diagnosed Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kantonsspital Olten</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kantonsspital Aarau</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Luzerner Kantonsspital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</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>
      The aim of the study is to test the efficacy, feasibility, and safety of a bicycle exercise&#xD;
      followed by an intensive lifestyle intervention for 3 months in patients with recent onset&#xD;
      and medically untreated type 2 diabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lifestyle intervention is a fundamental aspect in the treatment of type 2 diabetes.&#xD;
      Implementation of lifestyle changes early after diagnosis often suffices to control metabolic&#xD;
      dysregulation and may even have a durable impact. However, implementation of these changes is&#xD;
      often difficult for multiple reasons including noncompliance as well as doubt on efficacy of&#xD;
      sport and diet changes compared to drugs. Furthermore, most patients with type 2 diabetes&#xD;
      remain asymptomatic for a prolonged period of time. Thus, they lack an immediate relief of&#xD;
      symptoms and do not feel the benefit of changes in lifestyle. Often, untreated type 2&#xD;
      diabetes first manifests itself with symptoms of polyuria and polydipsia. This offers a&#xD;
      unique opportunity to demonstrate the potential of lifestyle changes. However, in daily&#xD;
      practice, symptomatic patients with polyuria and polydipsia or with HbA1c levels &gt;10% at&#xD;
      diagnosis are typically referred to an emergency room, hospitalized and treated with drugs as&#xD;
      a first line treatment.&#xD;
&#xD;
      In the present study, we aim to implement a lifestyle intervention as a first-line treatment&#xD;
      in recent onset type 2 diabetes. In the emergency room, the bed will symbolically be removed&#xD;
      and the patient requested to perform a bicycle exercise. Non-ER patients will be invited to&#xD;
      perform the bicycle exercise as soon as possible. We expect from this educational trigger&#xD;
      that patients will realize the therapeutic power of sport. Preliminary interventions using&#xD;
      this approach at our emergency room demonstrated the potential of such an intervention.&#xD;
      However, internal and external validation, efficacy and safety of a lifestyle intervention in&#xD;
      an emergency room remain to be shown in a multi-center controlled study.&#xD;
&#xD;
      The primary endpoint of this study is achievement of metabolic control without anti-diabetic&#xD;
      medication 3 months after study enrollment. For the purpose of this study, metabolic control&#xD;
      is defined as an HbA1c below a target stratified for three groups according to HbA1c at&#xD;
      baseline: HbA1c &gt;14% a target of &lt; 10%; HbA1c &lt; 14% and &gt; 10% a target of &lt; 8%; HbA1c &lt; 10% a&#xD;
      target of &lt; 7.5%.&#xD;
&#xD;
      Patients will be randomized either to standard care or to a bicycle exercise followed by an&#xD;
      intensive lifestyle intervention on top of non-pharmacological standard care.&#xD;
&#xD;
      After rehydration, patients allocated to the intensified lifestyle intervention group will be&#xD;
      instructed to perform 30 minutes of bicycle exercise at 60 % of the calculated maximum heart&#xD;
      rate (according to Franckowiak et al.) followed by an intensive lifestyle intervention.&#xD;
      Patients will be discharged if the clinical status is stable and no comorbidities require&#xD;
      further hospitalization. Follow-up visits at the Clinic of Endocrinology for further&#xD;
      instructions and consultation will be carried out after 2, 7, 30, 60 and 90 days, half a year&#xD;
      and a year.&#xD;
&#xD;
      In order to monitor blood glucose levels, patients will be instructed on visit 2 to take&#xD;
      measurements at home and will be asked to send their fasting glucose levels of the first week&#xD;
      to the study team for monitoring of the metabolic situation. This will also be done in the&#xD;
      week before visits of day 30 and 90.&#xD;
&#xD;
      The schedule for the intervention arm consists of 3 to 5 aerobic training sessions (duration&#xD;
      15-40 minutes each) and 2 resistance trainings per week, as well as weekly motivational&#xD;
      coaching via telephone by the study psychologist. Everyday activity will be objectively&#xD;
      monitored using the patient's mobile phone and a blinded actigraph (activity tracker).&#xD;
      Exercise sessions will be monitored by weekly phone calls and documented. To assess baseline&#xD;
      physical activity all patients will fill in the SIMPAQ questionnaire at baseline and at 6&#xD;
      months.&#xD;
&#xD;
      Measurement of clinical parameters (heart rate, blood pressure), venous blood gas analysis&#xD;
      (pH, pCO2, base excess, bicarbonate) at baseline and 120 min after beginning of bicycle&#xD;
      exercise. Blood glucose levels at baseline and 30, 60 and 120 min after beginning of bicycle&#xD;
      exercise. Blood glucose levels, vital parameters, concomitant medication after 2, 7, 30, 60&#xD;
      and 90 days; HbA1c at baseline, 2 (only intervention group), 3 and 6 months and one year;&#xD;
      physical activity at baseline, 3 and 6 months. In the intervention group additional&#xD;
      self-measurements of blood glucose levels during the first week and within the week before&#xD;
      visit at day 30 and 90 after randomization.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">June 2024</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>metabolic control</measure>
    <time_frame>3 months</time_frame>
    <description>fasting glucose &lt; 7.6 mM and HbA1c below a target stratified for three groups according to HbA1c at baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Absolute HbA1c reduction per stratification group</measure>
    <time_frame>3 months</time_frame>
    <description>Absolute HbA1c (% points) reduction after 3 months per stratification group (groups consist of HbA1c &gt;14%; HbA1c &lt;14% and &gt;10%; HbA1c &lt;10%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute HbA1c reduction per stratification group</measure>
    <time_frame>6 months</time_frame>
    <description>Absolute HbA1c (% points) reduction after 6 months per stratification group (groups consist of HbA1c &gt;14%; HbA1c &lt;14% and &gt;10%; HbA1c &lt;10%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients achieving HbA1c target in each stratification group</measure>
    <time_frame>3 months</time_frame>
    <description>Proportion (%) of patients achieving target per stratified group after 3 months without anti-diabetic medication other than Metformin (groups consist of HbA1c &gt;14%, HbA1c &lt;14% and &gt;10% and HbA1c &lt;10%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility of bicycle exercise at study enrollment in the ER</measure>
    <time_frame>2 hours</time_frame>
    <description>Feasibility of bicycle exercise at study enrollment in the ER, defined as absence of problem reports through the study team</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients achieving HbA1c target in each stratification group</measure>
    <time_frame>6 months</time_frame>
    <description>Proportion (%) of patients achieving target per stratified group after 6 months without anti-diabetic medication other than Metformin (groups consist of HbA1c &gt;14%, HbA1c &lt;14% and &gt;10% and HbA1c &lt;10%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in heart rate after bicycle intervention</measure>
    <time_frame>2 hours</time_frame>
    <description>Changes in heart rate (beats per minute) at the end and 120 min after bicycle exercise in the emergency room compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in respiratory rate after bicycle intervention</measure>
    <time_frame>2 hours</time_frame>
    <description>Changes in respiratory rate (breaths per minute) at the end and 120 min after bicycle exercise in the emergency room compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in blood pressure after bicycle intervention</measure>
    <time_frame>2 hours</time_frame>
    <description>Changes in blood pressure (mmHg) at the end and 120 min after bicycle exercise in the emergency room compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in blood glucose after bicycle intervention</measure>
    <time_frame>2 hours</time_frame>
    <description>Changes in blood glucose (mmol/l) at the end and 120 min after bicycle exercise in the emergency room compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in pH after bicycle intervention</measure>
    <time_frame>2 hours</time_frame>
    <description>Changes in pH at the end and 120 min after bicycle exercise in the emergency room compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in base excess after bicycle intervention</measure>
    <time_frame>2 hours</time_frame>
    <description>Changes in base excess (BE) at the end and 120 min after bicycle exercise in the emergency room compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in bicarbonate after bicycle intervention</measure>
    <time_frame>2 hours</time_frame>
    <description>Changes in bicarbonate (mmol/l) at the end and 120 min after bicycle exercise in the emergency room compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of exercise related Adverse Events (Safety) during bicycle exercise in the ER</measure>
    <time_frame>2 hours</time_frame>
    <description>Incidence of exercise related Adverse Events (cardiac, circulatory, pulmonary, neurologic complications) during bicycle exercise after diabetes diagnosis in the ER</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)</measure>
    <time_frame>6 months</time_frame>
    <description>Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) during intensive lifestyle intervention after new diagnosis of type 2 diabetes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Re-hospitalization rate</measure>
    <time_frame>3 months</time_frame>
    <description>Re-hospitalizations within 3 months after discharge from the emergency room.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Re-consultation rate</measure>
    <time_frame>3 months</time_frame>
    <description>Rate of unplanned re-consultations within 3 months after discharge from the emergency room.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in HbA1c at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in HbA1c (in % points) at 6 months compared to baseline assessed by blood sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in physical activity at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in physical activity at 6 months compared to baseline assessed by SIMPAQ questionnaire and actigraph.&#xD;
The SIMPAQ (Simple Physical Activity Questionnaire) measures daily physical activity. Time spent sedentary and active is measured in hours per day.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of antidiabetic medication at 30 days</measure>
    <time_frame>30 days</time_frame>
    <description>Number of antidiabetic medication at 30 compared to baseline in both arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of antidiabetic medication 60 days</measure>
    <time_frame>60 days</time_frame>
    <description>Number of antidiabetic medication 60 days compared to baseline in both arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of antidiabetic medication at 90 days</measure>
    <time_frame>90 months</time_frame>
    <description>Number of antidiabetic medication at 90 days compared to baseline in both arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dosage of antidiabetic medication at 30</measure>
    <time_frame>30 days</time_frame>
    <description>Dosage of antidiabetic medication at 30 days compared to baseline in both arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dosage of antidiabetic medication at 60 days</measure>
    <time_frame>60 days</time_frame>
    <description>Dosage of antidiabetic medication at 60 days compared to baseline in both arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dosage of antidiabetic medication at 90 days</measure>
    <time_frame>90 days</time_frame>
    <description>Dosage of antidiabetic medication at 90 days compared to baseline in both arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life by SF-36 Questionnaire</measure>
    <time_frame>6 months</time_frame>
    <description>Quality of life at 6 months in intervention group as compared to standard of care as assessed by SF-36 questionnaire. The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">62</enrollment>
  <condition>Life Style</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with intensive Lifestyle intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients with Standard Diabetes care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Lifestyle Intervention</intervention_name>
    <description>Physical activity program: 3-5 aerobic training sessions (15-40 minutes each) per week, combined with 2 resistance training per week as well as motivational coaching via telephone Nutritional counseling</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent as documented by signature&#xD;
&#xD;
          -  Type 2 diabetes diagnosed within the last two years according to the American Diabetes&#xD;
             Association (ADA) criteria&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  HbA1c ≥ 7.5 %&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically instable patient as defined by the physicians on duty including signs of&#xD;
             new cardiac ischemia in the ECG, systolic blood pressure ≥ 200 mmHg, fever ≥ 38.5 °C,&#xD;
             symptoms of SIRS or reduced vigilance.&#xD;
&#xD;
          -  Anti-diabetic medication for ≥ 24 hours&#xD;
&#xD;
          -  Inability to perform a bicycle exercise during 30 minutes&#xD;
&#xD;
          -  Previous lifestyle-intervention by an endocrinologist&#xD;
&#xD;
          -  Engagement in physical activity more than five times per week&#xD;
&#xD;
          -  Enrollment in other interventional study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marc Y Donath, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Basel, Switzerland</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marc Y Donath, Prof.</last_name>
    <phone>0041 61 265 50 78</phone>
    <email>marc.donath@usb.ch</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Nicole S Goetz, MD</last_name>
    <phone>0041 61 328 58 81</phone>
    <email>nicole.goetz@usb.ch</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cantonal Hospital Aarau</name>
      <address>
        <city>Aarau</city>
        <state>Aargau</state>
        <zip>5001</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Beat Müller, Prof.</last_name>
      <phone>0041 62 838 4141</phone>
      <email>beat.mueller@ksa.ch</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospital Basel</name>
      <address>
        <city>Basel</city>
        <state>Basel-Stadt</state>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marc Y Donath, Prof.</last_name>
      <phone>0041 61 265 50 78</phone>
      <email>marc.donath@usb.ch</email>
    </contact>
    <contact_backup>
      <last_name>Matthias Hepprich, MD</last_name>
      <phone>0041 61 328 60 77</phone>
      <email>matthias.hepprich@usb.ch</email>
    </contact_backup>
    <investigator>
      <last_name>Jonathan Mudry, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cantonal Hospital Olten</name>
      <address>
        <city>Olten</city>
        <state>Solothurn</state>
        <zip>4600</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gottfried Rudofsky, Prof.</last_name>
      <phone>0041 62 311 44 94</phone>
      <email>gottfried.rudofsky@spital.so.ch</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hopital du Jura</name>
      <address>
        <city>Delémont</city>
        <zip>2800</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marc Donath, Prof. Dr. med.</last_name>
      <email>marc.donath@usb.ch</email>
    </contact>
    <investigator>
      <last_name>Marc Donath, Prof. Dr. med.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yoann Aubry, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cantonal Hospital Lucerne</name>
      <address>
        <city>Lucerne</city>
        <zip>6000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Christoph Henzen, Prof.</last_name>
      <phone>0041 41 205 51 01</phone>
      <email>christoph.henzen@luks.ch</email>
    </contact>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>November 30, 2022</last_update_submitted>
  <last_update_submitted_qc>November 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Life Style Intervention</keyword>
  <keyword>Type 2 Diabetes mellitus</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 25, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT03827382/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03827382
org study id: 2018-01920
nct id: NCT03827382
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to test the efficacy, feasibility, and safety of a bicycle exercise
      followed by an intensive lifestyle intervention for 3 months in patients with recent onset
      and medically untreated type 2 diabetes.
Lifestyle intervention is a fundamental aspect in the treatment of type 2 diabetes.
      Implementation of lifestyle changes early after diagnosis often suffices to control metabolic
      dysregulation and may even have a durable impact. However, implementation of these changes is
      often difficult for multiple reasons including noncompliance as well as doubt on efficacy of
      sport and diet changes compared to drugs. Furthermore, most patients with type 2 diabetes
      remain asymptomatic for a prolonged period of time. Thus, they lack an immediate relief of
      symptoms and do not feel the benefit of changes in lifestyle. Often, untreated type 2
      diabetes first manifests itself with symptoms of polyuria and polydipsia. This offers a
      unique opportunity to demonstrate the potential of lifestyle changes. However, in daily
      practice, symptomatic patients with polyuria and polydipsia or with HbA1c levels >10% at
      diagnosis are typically referred to an emergency room, hospitalized and treated with drugs as
      a first line treatment.

      In the present study, we aim to implement a lifestyle intervention as a first-line treatment
      in recent onset type 2 diabetes. In the emergency room, the bed will symbolically be removed
      and the patient requested to perform a bicycle exercise. Non-ER patients will be invited to
      perform the bicycle exercise as soon as possible. We expect from this educational trigger
      that patients will realize the therapeutic power of sport. Preliminary interventions using
      this approach at our emergency room demonstrated the potential of such an intervention.
      However, internal and external validation, efficacy and safety of a lifestyle intervention in
      an emergency room remain to be shown in a multi-center controlled study.

      The primary endpoint of this study is achievement of metabolic control without anti-diabetic
      medication 3 months after study enrollment. For the purpose of this study, metabolic control
      is defined as an HbA1c below a target stratified for three groups according to HbA1c at
      baseline: HbA1c >14% a target of < 10%; HbA1c < 14% and > 10% a target of < 8%; HbA1c < 10% a
      target of < 7.5%.

      Patients will be randomized either to standard care or to a bicycle exercise followed by an
      intensive lifestyle intervention on top of non-pharmacological standard care.

      After rehydration, patients allocated to the intensified lifestyle intervention group will be
      instructed to perform 30 minutes of bicycle exercise at 60 % of the calculated maximum heart
      rate (according to Franckowiak et al.) followed by an intensive lifestyle intervention.
      Patients will be discharged if the clinical status is stable and no comorbidities require
      further hospitalization. Follow-up visits at the Clinic of Endocrinology for further
      instructions and consultation will be carried out after 2, 7, 30, 60 and 90 days, half a year
      and a year.

      In order to monitor blood glucose levels, patients will be instructed on visit 2 to take
      measurements at home and will be asked to send their fasting glucose levels of the first week
      to the study team for monitoring of the metabolic situation. This will also be done in the
      week before visits of day 30 and 90.

      The schedule for the intervention arm consists of 3 to 5 aerobic training sessions (duration
      15-40 minutes each) and 2 resistance trainings per week, as well as weekly motivational
      coaching via telephone by the study psychologist. Everyday activity will be objectively
      monitored using the patient's mobile phone and a blinded actigraph (activity tracker).
      Exercise sessions will be monitored by weekly phone calls and documented. To assess baseline
      physical activity all patients will fill in the SIMPAQ questionnaire at baseline and at 6
      months.

      Measurement of clinical parameters (heart rate, blood pressure), venous blood gas analysis
      (pH, pCO2, base excess, bicarbonate) at baseline and 120 min after beginning of bicycle
      exercise. Blood glucose levels at baseline and 30, 60 and 120 min after beginning of bicycle
      exercise. Blood glucose levels, vital parameters, concomitant medication after 2, 7, 30, 60
      and 90 days; HbA1c at baseline, 2 (only intervention group), 3 and 6 months and one year;
      physical activity at baseline, 3 and 6 months. In the intervention group additional
      self-measurements of blood glucose levels during the first week and within the week before
      visit at day 30 and 90 after randomization.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: metabolic control
time frame: 3 months
description: fasting glucose < 7.6 mM and HbA1c below a target stratified for three groups according to HbA1c at baseline.
measure: Absolute HbA1c reduction per stratification group
time frame: 3 months
description: Absolute HbA1c (% points) reduction after 3 months per stratification group (groups consist of HbA1c >14%; HbA1c <14% and >10%; HbA1c <10%)
measure: Absolute HbA1c reduction per stratification group
time frame: 6 months
description: Absolute HbA1c (% points) reduction after 6 months per stratification group (groups consist of HbA1c >14%; HbA1c <14% and >10%; HbA1c <10%)
measure: Proportion of patients achieving HbA1c target in each stratification group
time frame: 3 months
description: Proportion (%) of patients achieving target per stratified group after 3 months without anti-diabetic medication other than Metformin (groups consist of HbA1c >14%, HbA1c <14% and >10% and HbA1c <10%)
measure: Feasibility of bicycle exercise at study enrollment in the ER
time frame: 2 hours
description: Feasibility of bicycle exercise at study enrollment in the ER, defined as absence of problem reports through the study team
measure: Proportion of patients achieving HbA1c target in each stratification group
time frame: 6 months
description: Proportion (%) of patients achieving target per stratified group after 6 months without anti-diabetic medication other than Metformin (groups consist of HbA1c >14%, HbA1c <14% and >10% and HbA1c <10%)
measure: Changes in heart rate after bicycle intervention
time frame: 2 hours
description: Changes in heart rate (beats per minute) at the end and 120 min after bicycle exercise in the emergency room compared to baseline
measure: Changes in respiratory rate after bicycle intervention
time frame: 2 hours
description: Changes in respiratory rate (breaths per minute) at the end and 120 min after bicycle exercise in the emergency room compared to baseline
measure: Changes in blood pressure after bicycle intervention
time frame: 2 hours
description: Changes in blood pressure (mmHg) at the end and 120 min after bicycle exercise in the emergency room compared to baseline
measure: Changes in blood glucose after bicycle intervention
time frame: 2 hours
description: Changes in blood glucose (mmol/l) at the end and 120 min after bicycle exercise in the emergency room compared to baseline
measure: Changes in pH after bicycle intervention
time frame: 2 hours
description: Changes in pH at the end and 120 min after bicycle exercise in the emergency room compared to baseline
measure: Changes in base excess after bicycle intervention
time frame: 2 hours
description: Changes in base excess (BE) at the end and 120 min after bicycle exercise in the emergency room compared to baseline
measure: Changes in bicarbonate after bicycle intervention
time frame: 2 hours
description: Changes in bicarbonate (mmol/l) at the end and 120 min after bicycle exercise in the emergency room compared to baseline
measure: Incidence of exercise related Adverse Events (Safety) during bicycle exercise in the ER
time frame: 2 hours
description: Incidence of exercise related Adverse Events (cardiac, circulatory, pulmonary, neurologic complications) during bicycle exercise after diabetes diagnosis in the ER
measure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
time frame: 6 months
description: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) during intensive lifestyle intervention after new diagnosis of type 2 diabetes
measure: Re-hospitalization rate
time frame: 3 months
description: Re-hospitalizations within 3 months after discharge from the emergency room.
measure: Re-consultation rate
time frame: 3 months
description: Rate of unplanned re-consultations within 3 months after discharge from the emergency room.
measure: Changes in HbA1c at 6 months
time frame: 6 months
description: Changes in HbA1c (in % points) at 6 months compared to baseline assessed by blood sample
measure: Changes in physical activity at 6 months
time frame: 6 months
description: Changes in physical activity at 6 months compared to baseline assessed by SIMPAQ questionnaire and actigraph.
The SIMPAQ (Simple Physical Activity Questionnaire) measures daily physical activity. Time spent sedentary and active is measured in hours per day.
measure: Number of antidiabetic medication at 30 days
time frame: 30 days
description: Number of antidiabetic medication at 30 compared to baseline in both arms
measure: Number of antidiabetic medication 60 days
time frame: 60 days
description: Number of antidiabetic medication 60 days compared to baseline in both arms
measure: Number of antidiabetic medication at 90 days
time frame: 90 months
description: Number of antidiabetic medication at 90 days compared to baseline in both arms
measure: Dosage of antidiabetic medication at 30
time frame: 30 days
description: Dosage of antidiabetic medication at 30 days compared to baseline in both arms
measure: Dosage of antidiabetic medication at 60 days
time frame: 60 days
description: Dosage of antidiabetic medication at 60 days compared to baseline in both arms
measure: Dosage of antidiabetic medication at 90 days
time frame: 90 days
description: Dosage of antidiabetic medication at 90 days compared to baseline in both arms
measure: Quality of life by SF-36 Questionnaire
time frame: 6 months
description: Quality of life at 6 months in intervention group as compared to standard of care as assessed by SF-36 questionnaire. The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
arm group label: Intervention
arm group type: Active Comparator
description: Patients with intensive Lifestyle intervention
arm group label: Control
arm group type: No Intervention
description: Patients with Standard Diabetes care
intervention type: Behavioral
intervention name: Lifestyle Intervention
description: Physical activity program: 3-5 aerobic training sessions (15-40 minutes each) per week, combined with 2 resistance training per week as well as motivational coaching via telephone Nutritional counseling
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marc Y Donath, Prof.
role: Principal Investigator
affiliation: University Hospital, Basel, Switzerland
last name: Marc Y Donath, Prof.
phone: 0041 61 265 50 78
email: marc.donath@usb.ch
last name: Nicole S Goetz, MD
phone: 0041 61 328 58 81
email: nicole.goetz@usb.ch
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
country: Switzerland
responsible party type: Sponsor
sharing ipd: No
provided document: 