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| Name | Class |
|---|---|
| Jessa Hospital | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| subjects with Type 1 Diabetes mellitus | Active Comparator | Type 1 diabetes patients without cardiovascular disease undergo autonomic function testing |
|
| Healthy controls | Placebo Comparator | healthy people without known disease undergo autonomic function testing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autonomic function testing | Diagnostic Test | autonomic function testing, ergospirometry, three questionnaires Other Names:
|
| Measure | Description | Time Frame |
|---|---|---|
| VO2 max | peak oxygen consumption | day 1 |
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Inclusion Criteria:
Exclusion Criteria:
Uncontrolled hypertension, atrial fibrillation and other cardiovascular conditions
Severe lung disease
Muscle deficiency
Medication with influence on the autonomic nervous system:
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| Name | Affiliation | Role |
|---|---|---|
| Renee De Busser, student | Hasselt University | Study Chair |
| Anika Nys, student | Hasselt University | Study Chair |
| Paul Dendale, prof. dr. | Jessa Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jessa Ziekenhuis | Hasselt | 3500 | Belgium |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |