Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes Mellitus.

Study Overview
=================
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.

Official Title
-----------------
Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes Mellitus.

Conditions
-----------------
Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Diagnostic Test: autonomic function testing


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: subjects with Type 1 Diabetes mellitus<br>Type 1 diabetes patients without cardiovascular disease undergo autonomic function testing | Diagnostic Test: autonomic function testing<br>* 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<br>|
| Placebo Comparator: Healthy controls<br>healthy people without known disease undergo autonomic function testing | Diagnostic Test: autonomic function testing<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VO2 max | peak oxygen consumption | day 1 |