Diabetes Mellitus, Type 1 Clinical Trial
Official title:
Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes Mellitus.
testing of autonomic function and relationship with exercise and Qol in diabetic patients and controls
Cardiovascular autonomic neuropathy is a common (sub)clinical symptom in persons with type 1
diabetes mellitus. Subjects in this non-commercial, monocentric, interventional study undergo
autonomic function tests, a maximal ergospirometry and three questionnaires about the quality
of life (EQ-5D-3L), the capacity to do physical activities (IPAQ) and the experience of
possible symptoms of autonomic dysfunction in daily life (SCOPA-AUT). In this way the
influence of type 1 diabetes mellitus on the quality of life, the exercise capacity and the
autonomic function can be studied.
The primary aim of this study investigates the potential correlations between the severity of
diabetic cardiovascular autonomic neuropathy (DCAN) and both the quality of life and the
exercise capacity. As a secondary aim, the influences of gender, age, number of years since
diagnosis of type 1 diabetes mellitus, VO2 max predicted, maximal heart rate during exercise,
minimal heart rate in rest, maximal RER (Respiratory exchange ratio) and relevant interaction
terms are studied.
In total 52 test subjects with type 1 diabetes mellitus and 27 matched control subjects are
selected to participate in this study.
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