RecruitingNot ApplicableNCT03827382
Bicycle Exercise and Lifestyle Intervention in Newly Diagnosed Diabetes
Sponsor
University Hospital, Basel, Switzerland
Enrollment
62 participants
Start Date
Feb 1, 2019
Study Type
INTERVENTIONAL
Conditions
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 untreated type 2 diabetes.
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- 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 Criteria6
- 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
Interventions
BEHAVIORALLifestyle Intervention
Physical activity program: 3-5 aerobic training sessions (15-40 minutes each) per week, combined with 2 resistance training per week as well as motivational coaching via telephone Nutritional counseling
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT03827382
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