Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes Mellitus.

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Diagnostic Test: autonomic function testing

• Registration Number: NCT03481374
• Lead Sponsor: Hasselt University

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.

Study Timeline

• Study Start: 2016-07-01
• Primary Completion: 2017-03-31
• Study Completion: 2017-03-31
• Study First Submitted: 2018-03-22
• Study First Submitted QC: 2018-03-22
• Study First Posted: 2018-03-29
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-14
• Last Update Posted: 2018-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
subjects with Type 1 Diabetes mellitus	autonomic function testing	Type 1 diabetes patients without cardiovascular disease undergo autonomic function testing
Healthy controls	autonomic function testing	healthy people without known disease undergo autonomic function testing

Primary Outcome Measures

Name	Time	Method
VO2 max	day 1	peak oxygen consumption

Trial Locations

Locations (1)

Jessa Ziekenhuis; 🇧🇪 Hasselt, Belgium