Clinical trial Recruiting at 3 sites Interventional Ages 18 and up

Bicycle exercise and lifestyle changes for newly diagnosed diabetes

Official title: Bicycle Exercise and Lifestyle Intervention in Newly Diagnosed Diabetes

Run by University Hospital, Basel, Switzerland · NCT03827382 · Data updated 2026-11-12

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

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment62 (estimated)
SponsorUniversity Hospital, Basel, Switzerland
Academic / other
Locations3 sites (Basel, Canton of Basel-City and 2 other locations)
StatusRecruiting
StartedFebruary 1, 2019
Main results expectedDecember 31, 2025
Study endsDecember 31, 2025
Registry record updatedFebruary 14, 2025
Trial IDNCT03827382 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Preliminary interventions using similar lifestyle approaches have shown promise, suggesting potential for success in this study.

Who can join: the full rules

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.