Bicycle exercise and lifestyle changes for newly diagnosed diabetes
Bicycle Exercise and Lifestyle Intervention in Newly Diagnosed Diabetes
NA · University Hospital, Basel, Switzerland · NCT03827382
This study tests whether a bicycle exercise program combined with lifestyle changes can help people recently diagnosed with type 2 diabetes manage their condition better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland (other) |
| Locations | 3 sites (Basel, Canton of Basel-City and 2 other locations) |
| Trial ID | NCT03827382 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness, feasibility, and safety of a bicycle exercise program followed by an intensive lifestyle intervention over three months for patients recently diagnosed with untreated type 2 diabetes. The intervention seeks to encourage lifestyle changes early in the disease process, which may help control metabolic dysregulation and provide long-term benefits. Participants will engage in bicycle exercise as a first-line treatment, with the goal of demonstrating the therapeutic power of physical activity. The study will include patients diagnosed within the last two years who meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been diagnosed with type 2 diabetes within the last two years and have an HbA1c level of 7.5% or higher.
Not a fit: Patients who are clinically unstable, on anti-diabetic medication, or unable to perform bicycle exercise for 30 minutes may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could empower patients to manage their diabetes through lifestyle changes rather than relying solely on medication.
How similar studies have performed: Preliminary interventions using similar lifestyle approaches have shown promise, suggesting potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Basel, Canton of Basel-City and 2 other locations
- University of Basel — Basel, Canton of Basel-City, Switzerland (RECRUITING)
- Cantonal Hospital Olten — Olten, Canton of Solothurn, Switzerland (RECRUITING)
- Hopital du Jura — Delémont, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Marc Y Donath, Prof. — University Hospital, Basel, Switzerland
- Study coordinator: Marc Y Donath, Prof.
- Email: marc.donath@usb.ch
- Phone: 0041 61 265 50 78
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Life Style, Life Style Intervention, Type 2 Diabetes mellitus