Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID03827382

Bicycle Exercise and Lifestyle Intervention in Newly Diagnosed Diabetes

Led by University Hospital, Basel, Switzerland · Updated on 2025-02-14

62

Participants Needed

3

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University Hospital, Basel, Switzerland

Lead Sponsor

K

Kantonsspital Olten

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness, feasibility, and safety of a bicycle exercise followed by an intensive lifestyle intervention over three months in patients recently diagnosed with and not yet treated for type 2 diabetes. The study focuses on early lifestyle changes as a first-line treatment to control metabolic problems without medication. This approach seeks to show the benefits of exercise and diet changes, especially in patients with symptoms like increased urination and thirst, who often receive immediate drug treatment instead. Participants are randomly assigned to either standard care or an intervention group that performs a 30-minute bicycle exercise at 60% of their maximum heart rate, followed by a lifestyle program including 3 to 5 aerobic sessions and 2 resistance trainings per week, plus weekly motivational coaching calls. The study involves a symbolic removal of the emergency room bed to encourage exercise immediately after diagnosis. Follow-up visits occur at 2, 7, 30, 60, and 90 days, as well as at 6 months and one year. During the study, participants will monitor blood glucose at home, sending fasting glucose readings to the research team for ongoing metabolic monitoring. Clinical measurements like heart rate, blood pressure, blood gases, and HbA1c will be taken at multiple time points. Activity levels will be tracked by mobile phone and an activity tracker. The main outcome is metabolic control without medication after 3 months, with additional evaluations of physical activity, safety, and quality of life over time.

CONDITIONS

Brief Title

Bicycle Exercise and Lifestyle Intervention in Newly Diagnosed Diabetes

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provided informed consent by signing
  • Diagnosed with type 2 diabetes within the last two years according to ADA criteria
  • At least 18 years of age
  • HbA1c level of 7.5% or higher
Not Eligible

You will not qualify if you...

  • Clinically unstable patients, including signs of new cardiac ischemia, very high blood pressure (systolic 20 mmHg), fever (38.5 dC or higher), symptoms of systemic inflammatory response syndrome, or reduced alertness
  • Use of anti-diabetic medication for 24 hours or more
  • Unable to perform 30 minutes of bicycle exercise
  • Previous lifestyle intervention by an endocrinologist
  • Engaging in physical activity more than five times per week
  • Participation in another interventional study

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 1 year

Participants randomized to the lifestyle intervention group perform an initial 30-minute bicycle exercise followed by an intensive lifestyle program including 3-5 aerobic and 2 resistance training sessions per week, plus weekly motivational coaching and nutritional counseling. Participants in the control group receive standard diabetes care.

Follow-up visits at days 2, 7, 30, 60, and 90, and at 6 months and 1 year

Follow-up

Duration - Up to 1 year

Participants continue monitoring of metabolic control and physical activity with assessments including blood glucose measurements at home and clinical evaluations during follow-up visits.

Home blood glucose measurements during first week and prior to visits at day 30 and 90; clinic visits as above

Trial Site Locations

Total: 3 locations

1

University of Basel

Basel, Canton of Basel-City, Switzerland, 4031

Actively Recruiting

2

Cantonal Hospital Olten

Olten, Canton of Solothurn, Switzerland, 4600

Actively Recruiting

3

Hopital du Jura

Delémont, Switzerland, 2800

Actively Recruiting

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Research Team

M

Marc Y Donath, Prof.

M

Matthias Hepprich, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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