Endocrine Abstracts

Background/Introduction: Lifestyle adaptations are crucial in the treatment of type 2 diabetes. However, implementation is difficult and patients especially with high glucose levels receive most often medication as first-line treatment instead of intensive lifestyle changes. We hypothesized that a primary lifestyle intervention as first-line treatment for newly diagnosed type 2 diabetes compared to standard of care is didactic, safe and can achieve metabolic control alone.

Methods: 62 Adult patients with untreated type 2 diabetes diagnosed within the last 2 years and HbA1c ≥ 7.5% will be included in the study if they are clinically stable. After inclusion, patients are randomized to either the intervention group or the control group. Control group receives standard-of-care. Patients in the intervention group are asked to perform a 30-minute bicycle exercise. Clinical parameters are collected and blood analysis is performed throughout the exercise. Afterwards, patients undergo an exercise program along with regular motivational coaching, nutritional and diabetes counseling. HbA1c and glucose are measured after 3 months, to determine whether the intervention was successful. Primary endpoint is achievement of metabolic control, defined as reduction in HbA1c below a certain threshold depending on initial HbA1c, without antidiabetic medication 3 months after study enrollment.

Results: We conducted an interim analysis with 16 patients. Attainment of metabolic control was similar in both groups, with 75% (n=8) of patients in the intervention group reaching metabolic control after 3 months, compared to 50% (n=8) in the control group (P=0.6084). Both groups showed a significant reduction in median HbA1c levels from baseline over 3 months, with a 34.5% reduction from 10.15% to 6.65% in the intervention group (P=0.0078) and a 25.9% reduction from 9.85% to 7.30% in the control group (P=0.0234). The initial educative bicycle exercise lowered median blood glucose from 12.2 mmol/l to 10.05 mmol/l (P=0.0078) after 30 minutes. No significant safety issues were reported.

Conclusion: Data from this interim analysis supports the hypothesis, that intensified lifestyle intervention without anti-diabetic medication is safe and at least as efficient at reducing HbA1c as conventional treatment in patients with new-onset type 2 diabetes, even for patients with severe metabolic decompensation with an HbA1c higher than 10%.