Status:
RECRUITING
Bicycle Exercise and Lifestyle Intervention in Newly Diagnosed Diabetes
Lead Sponsor:
University Hospital, Basel, Switzerland
Collaborating Sponsors:
Kantonsspital Olten
Conditions:
Life Style
Eligibility:
All Genders
18+ years
Phase:
NA
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 unt...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT03827382
Start Date
February 1 2019
End Date
December 31 2025
Last Update
February 14 2025
Active Locations (3)
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1
University of Basel
Basel, Canton of Basel-City, Switzerland, 4031
2
Cantonal Hospital Olten
Olten, Canton of Solothurn, Switzerland, 4600
3
Hopital du Jura
Delémont, Switzerland, 2800