Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes Mellitus.

Hasselt University

Status: Completed

Conditions: Diabetes Mellitus, Type 1

Treatments: Diagnostic Test: autonomic function testing

Study type: Interventional

Funder types: Other

Identifiers

NCT03481374

CVDIABMEL-1

Details and patient eligibility

About

testing of autonomic function and relationship with exercise and Qol in diabetic patients and controls

Full 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.

Enrollment: 79 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

79 participants in 2 patient groups, including a placebo group

subjects with Type 1 Diabetes mellitus

Active Comparator group

Description:

Type 1 diabetes patients without cardiovascular disease undergo autonomic function testing

Treatment:

Diagnostic Test: autonomic function testing

Healthy controls

Placebo Comparator group

Description:

healthy people without known disease undergo autonomic function testing

Treatment:

Diagnostic Test: autonomic function testing