Cardiovascular Autonomic Neuropathy in… | Clinical Trial

Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jessa Ziekenhuis

Hasselt, 3500, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

autonomic function testing

Diagnostic Test

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

Primary outcomes

VO2 max

Time frame: day 1

peak oxygen consumption

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

Jessa Hospital

Registry information

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Mar 29, 2018
Registry last updated: Apr 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed