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Bicycle Exercise and Lifestyle Intervention in Newly Diagnosed Diabetes (BELIFE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03827382
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : May 27, 2020
Sponsor:
Collaborators:
Kantonsspital Olten
Kantonsspital Aarau
Luzerner Kantonsspital
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Life Style Behavioral: Lifestyle Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bicycle Exercise and Lifestyle Intervention in Newly Diagnosed Diabetes
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Intervention
Patients with intensive Lifestyle intervention
Behavioral: Lifestyle Intervention
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

No Intervention: Control
Patients with Standard Diabetes care



Primary Outcome Measures :
  1. metabolic control [ Time Frame: 3 months ]
    fasting glucose < 7.6 mM and HbA1c below a target stratified for three groups according to HbA1c at baseline.


Secondary Outcome Measures :
  1. Absolute HbA1c reduction per stratification group [ Time Frame: 3 months ]
    Absolute HbA1c (% points) reduction after 3 months per stratification group (groups consist of HbA1c >14%; HbA1c <14% and >10%; HbA1c <10%)

  2. Absolute HbA1c reduction per stratification group [ Time Frame: 6 months ]
    Absolute HbA1c (% points) reduction after 6 months per stratification group (groups consist of HbA1c >14%; HbA1c <14% and >10%; HbA1c <10%)

  3. Proportion of patients achieving HbA1c target in each stratification group [ Time Frame: 3 months ]
    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%)

  4. Feasibility of bicycle exercise at study enrollment in the ER [ Time Frame: 2 hours ]
    Feasibility of bicycle exercise at study enrollment in the ER, defined as absence of problem reports through the study team

  5. Proportion of patients achieving HbA1c target in each stratification group [ Time Frame: 6 months ]
    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%)

  6. Changes in heart rate after bicycle intervention [ Time Frame: 2 hours ]
    Changes in heart rate (beats per minute) at the end and 120 min after bicycle exercise in the emergency room compared to baseline

  7. Changes in respiratory rate after bicycle intervention [ Time Frame: 2 hours ]
    Changes in respiratory rate (breaths per minute) at the end and 120 min after bicycle exercise in the emergency room compared to baseline

  8. Changes in blood pressure after bicycle intervention [ Time Frame: 2 hours ]
    Changes in blood pressure (mmHg) at the end and 120 min after bicycle exercise in the emergency room compared to baseline

  9. Changes in blood glucose after bicycle intervention [ Time Frame: 2 hours ]
    Changes in blood glucose (mmol/l) at the end and 120 min after bicycle exercise in the emergency room compared to baseline

  10. Changes in pH after bicycle intervention [ Time Frame: 2 hours ]
    Changes in pH at the end and 120 min after bicycle exercise in the emergency room compared to baseline

  11. Changes in base excess after bicycle intervention [ Time Frame: 2 hours ]
    Changes in base excess (BE) at the end and 120 min after bicycle exercise in the emergency room compared to baseline

  12. Changes in bicarbonate after bicycle intervention [ Time Frame: 2 hours ]
    Changes in bicarbonate (mmol/l) at the end and 120 min after bicycle exercise in the emergency room compared to baseline

  13. Incidence of exercise related Adverse Events (Safety) during bicycle exercise in the ER [ Time Frame: 2 hours ]
    Incidence of exercise related Adverse Events (cardiac, circulatory, pulmonary, neurologic complications) during bicycle exercise after diabetes diagnosis in the ER

  14. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: 6 months ]
    Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) during intensive lifestyle intervention after new diagnosis of type 2 diabetes

  15. Re-hospitalization rate [ Time Frame: 3 months ]
    Re-hospitalizations within 3 months after discharge from the emergency room.

  16. Re-consultation rate [ Time Frame: 3 months ]
    Rate of unplanned re-consultations within 3 months after discharge from the emergency room.

  17. Changes in HbA1c at 6 months [ Time Frame: 6 months ]
    Changes in HbA1c (in % points) at 6 months compared to baseline assessed by blood sample

  18. Changes in physical activity at 6 months [ Time Frame: 6 months ]

    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.


  19. Number of antidiabetic medication at 30 days [ Time Frame: 30 days ]
    Number of antidiabetic medication at 30 compared to baseline in both arms

  20. Number of antidiabetic medication 60 days [ Time Frame: 60 days ]
    Number of antidiabetic medication 60 days compared to baseline in both arms

  21. Number of antidiabetic medication at 90 days [ Time Frame: 90 months ]
    Number of antidiabetic medication at 90 days compared to baseline in both arms

  22. Dosage of antidiabetic medication at 30 [ Time Frame: 30 days ]
    Dosage of antidiabetic medication at 30 days compared to baseline in both arms

  23. Dosage of antidiabetic medication at 60 days [ Time Frame: 60 days ]
    Dosage of antidiabetic medication at 60 days compared to baseline in both arms

  24. Dosage of antidiabetic medication at 90 days [ Time Frame: 90 days ]
    Dosage of antidiabetic medication at 90 days compared to baseline in both arms

  25. Quality of life by SF-36 Questionnaire [ Time Frame: 6 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent as documented by signature
  • Type 2 diabetes diagnosed within the last two years according to the American Diabetes Association (ADA) criteria
  • Age ≥ 18 years
  • HbA1c ≥ 7.5 %

Exclusion Criteria:

  • Clinically instable patient as defined by the physicians on duty including signs of new cardiac ischemia in the ECG, systolic blood pressure ≥ 200 mmHg, fever ≥ 38.5 °C, symptoms of SIRS or reduced vigilance.
  • Anti-diabetic medication for ≥ 24 hours
  • Inability to perform a bicycle exercise during 30 minutes
  • Previous lifestyle-intervention by an endocrinologist
  • Engagement in physical activity more than five times per week
  • Enrollment in other interventional study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03827382


Contacts
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Contact: Marc Y Donath, Prof. 0041 61 265 50 78 marc.donath@usb.ch
Contact: Nicole S Goetz, MD 0041 61 328 58 81 nicole.goetz@usb.ch

Locations
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Switzerland
Cantonal Hospital Aarau Not yet recruiting
Aarau, Aargau, Switzerland, 5001
Contact: Beat Müller, Prof.    0041 62 838 4141    beat.mueller@ksa.ch   
University Hospital Basel Recruiting
Basel, Basel-Stadt, Switzerland, 4031
Contact: Marc Y Donath, Prof.    0041 61 265 50 78    marc.donath@usb.ch   
Contact: Matthias Hepprich, MD    0041 61 328 60 77    matthias.hepprich@usb.ch   
Sub-Investigator: Jonathan Mudry, MD, PhD         
Cantonal Hospital Olten Recruiting
Olten, Solothurn, Switzerland, 4600
Contact: Gottfried Rudofsky, Prof.    0041 62 311 44 94    gottfried.rudofsky@spital.so.ch   
Cantonal Hospital Lucerne Not yet recruiting
Lucerne, Switzerland, 6000
Contact: Christoph Henzen, Prof.    0041 41 205 51 01    christoph.henzen@luks.ch   
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Kantonsspital Olten
Kantonsspital Aarau
Luzerner Kantonsspital
Investigators
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Principal Investigator: Marc Y Donath, Prof. University Hospital, Basel, Switzerland
  Study Documents (Full-Text)

Documents provided by University Hospital, Basel, Switzerland:
Study Protocol  [PDF] September 25, 2019

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03827382    
Other Study ID Numbers: 2018-01920
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
Life Style Intervention
Type 2 Diabetes mellitus