Bicycle Exercise and Lifestyle Intervention in Newly Diagnosed Diabetes

Lifestyle intervention is a fundamental aspect in the treatment of type 2 diabetes. Implementation of lifestyle changes early after diagnosis often suffices to control metabolic dysregulation and may even have a durable impact. However, implementation of these changes is often difficult for multiple reasons including noncompliance as well as doubt on efficacy of sport and diet changes compared to drugs. Furthermore, most patients with type 2 diabetes remain asymptomatic for a prolonged period of time. Thus, they lack an immediate relief of symptoms and do not feel the benefit of changes in lifestyle. Often, untreated type 2 diabetes first manifests itself with symptoms of polyuria and polydipsia. This offers a unique opportunity to demonstrate the potential of lifestyle changes. However, in daily practice, symptomatic patients with polyuria and polydipsia or with HbA1c levels >10% at diagnosis are typically referred to an emergency room, hospitalized and treated with drugs as a first line treatment.

In the present study, we aim to implement a lifestyle intervention as a first-line treatment in recent onset type 2 diabetes. In the emergency room, the bed will symbolically be removed and the patient requested to perform a bicycle exercise. Non-ER patients will be invited to perform the bicycle exercise as soon as possible. We expect from this educational trigger that patients will realize the therapeutic power of sport. Preliminary interventions using this approach at our emergency room demonstrated the potential of such an intervention. However, internal and external validation, efficacy and safety of a lifestyle intervention in an emergency room remain to be shown in a multi-center controlled study.

The primary endpoint of this study is achievement of metabolic control without anti-diabetic medication 3 months after study enrollment. For the purpose of this study, metabolic control is defined as an HbA1c below a target stratified for three groups according to HbA1c at baseline: HbA1c >14% a target of < 10%; HbA1c < 14% and > 10% a target of < 8%; HbA1c < 10% a target of < 7.5%.

Patients will be randomized either to standard care or to a bicycle exercise followed by an intensive lifestyle intervention on top of non-pharmacological standard care.

After rehydration, patients allocated to the intensified lifestyle intervention group will be instructed to perform 30 minutes of bicycle exercise at 60 % of the calculated maximum heart rate (according to Franckowiak et al.) followed by an intensive lifestyle intervention. Patients will be discharged if the clinical status is stable and no comorbidities require further hospitalization. Follow-up visits at the Clinic of Endocrinology for further instructions and consultation will be carried out after 2, 7, 30, 60 and 90 days, half a year and a year.