Health Trials

Bicycle Exercise and Lifestyle Intervention in Newly Diagnosed Diabetes

ConditionLife Style
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Basel, Switzerland

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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 %

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lifestyle Intervention

    Behavioral

    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

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: InterventionActive comparator 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

metabolic control

fasting glucose \< 7.6 mM and HbA1c below a target stratified for three groups according to HbA1c at baseline.

Time frame
3 months

Secondary outcomes

1

Absolute HbA1c reduction per stratification group

Absolute HbA1c (% points) reduction after 3 months per stratification group (groups consist of HbA1c \>14%; HbA1c \<14% and \>10%; HbA1c \<10%)

Time frame
3 months
2

Absolute HbA1c reduction per stratification group

Absolute HbA1c (% points) reduction after 6 months per stratification group (groups consist of HbA1c \>14%; HbA1c \<14% and \>10%; HbA1c \<10%)

Time frame
6 months
3

Proportion of patients achieving HbA1c target in each stratification group

Proportion (%) of patients achieving target per stratified group after 3 months without anti-diabetic medication other than Metformin (groups consist of HbA1c \>14%, HbA1c \<14% and \>10% and HbA1c \<10%)

Time frame
3 months
4

Feasibility of bicycle exercise at study enrollment in the ER

Feasibility of bicycle exercise at study enrollment in the ER, defined as absence of problem reports through the study team

Time frame
2 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Basel, Switzerland

Lead sponsor

Kantonsspital Olten

Collaborator

Source ClinicalTrials.gov
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