Clinical trial NCT03481374: Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes Mellitus.
Official title: Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes Mellitus.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Jessa Hospital
First posted: 2018-03-29
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: VO2 max
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
Study officials:
affiliation: Hasselt University
name: Renee De Busser, student
role: STUDY_CHAIR
affiliation: Hasselt University
name: Anika Nys, student
role: STUDY_CHAIR
affiliation: Jessa Hospital
name: Paul Dendale, prof. dr.
role: PRINCIPAL_INVESTIGATOR
References: