Bicycle Exercise and Lifestyle Intervention in Newly Diagnosed Diabetes
BELIFE
1 other identifier
interventional
62
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2019
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2018
CompletedFirst Posted
Study publicly available on registry
February 1, 2019
CompletedStudy Start
First participant enrolled
February 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedFebruary 14, 2025
February 1, 2025
6.9 years
December 6, 2018
February 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
metabolic control
fasting glucose \< 7.6 mM and HbA1c below a target stratified for three groups according to HbA1c at baseline.
3 months
Secondary Outcomes (25)
Absolute HbA1c reduction per stratification group
3 months
Absolute HbA1c reduction per stratification group
6 months
Proportion of patients achieving HbA1c target in each stratification group
3 months
Feasibility of bicycle exercise at study enrollment in the ER
2 hours
Proportion of patients achieving HbA1c target in each stratification group
6 months
- +20 more secondary outcomes
Study Arms (2)
Intervention
ACTIVE COMPARATORPatients with intensive Lifestyle intervention
Control
NO INTERVENTIONPatients with Standard Diabetes care
Interventions
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
Eligibility Criteria
You may qualify if:
- 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 %
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Basel, Switzerlandlead
- Kantonsspital Oltencollaborator
Study Sites (3)
University of Basel
Basel, Canton of Basel-City, 4031, Switzerland
Cantonal Hospital Olten
Olten, Canton of Solothurn, 4600, Switzerland
Hopital du Jura
Delémont, 2800, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marc Y Donath, Prof.
University Hospital, Basel, Switzerland
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2018
First Posted
February 1, 2019
Study Start
February 1, 2019
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
February 14, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share