An interventional study of autonomic function testing in Diabetes Mellitus, Type 1, sponsored by Hasselt University. Completed at 1 site in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-17.
Sponsored by Hasselt University · Not applicable, Interventional, and Screening
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.
Exclusion Criteria:
Medication with influence on the autonomic nervous system:
Type 1 diabetes patients without cardiovascular disease undergo autonomic function testing
Diagnostic Test: autonomic function testing
healthy people without known disease undergo autonomic function testing
Diagnostic Test: autonomic function testing
autonomic function testing, ergospirometry, three questionnaires Other Names: * The autonomic function tests consist of five tests: * The Valsalva maneuver * The isometric handgrip test * The deep breathing test * The cold pressor test * A short head-up tilt test * A maximal ergospirometry * Three questionnaires: * EQ-5D-3L: quality of life * IPAQ: capacity to do physical activities
VO2 max
peak oxygen consumption
Time frame: day 1
Plan to share: Undecided
No publications or documents are linked to this record.
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Hasselt University