Bicycle Exercise and Lifestyle Intervention in Newly Diagnosed Diabetes
Recruiting · NCT03827382 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Basel, Switzerland
View the official record on ClinicalTrials.gov →Interventions studied
Lifestyle Intervention
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
3 locations listed.
- Hopital du Jura - Delémont, Switzerland
- University of Basel - Basel, Canton of Basel-City, Switzerland
- Cantonal Hospital Olten - Olten, Canton of Solothurn, Switzerland