Diabetes Mellitus, Type 1
Conditions
Brief summary
testing of autonomic function and relationship with exercise and Qol in diabetic patients and controls
Detailed description
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.
Interventions
DIAGNOSTIC_TESTautonomic 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
Sponsors
Jessa Hospital
Hasselt University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Type 1 diabetes mellitus (only for the group of subjects with diabetes mellitus) * At least two years with diagnosis of type 1 diabetes mellitus * Subject is in a stable condition * No hospitalization for any reason in the past three months * 18 years or older * Being capable of doing physical activities * Understand the study design and the informed consent * Sign the informed consent * No simultaneously participation to another study * Being capable of moving to the study center
Exclusion criteria
* Uncontrolled hypertension, atrial fibrillation and other cardiovascular conditions * Severe lung disease * Muscle deficiency * Medication with influence on the autonomic nervous system: * Beta blockers * Alfa blockers * Antidepressants * Non-catecholamines * (anti) cholinergic medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VO2 max | day 1 | peak oxygen consumption |
Countries
Belgium
Outcome results
None listed