Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes Mellitus.

NCT ID: NCT03481374

Last Updated: 2018-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-01
• Study Completion Date: 2017-03-31

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.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

subjects with Type 1 Diabetes mellitus

Type 1 diabetes patients without cardiovascular disease undergo autonomic function testing

Group Type: ACTIVE_COMPARATOR

autonomic function testing

Intervention Type: 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

Healthy controls

healthy people without known disease undergo autonomic function testing

Group Type: PLACEBO_COMPARATOR

autonomic function testing

Intervention Type: 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

Interventions

autonomic function testing

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

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jessa Hospital

OTHER

Sponsor Role: collaborator

Hasselt University

OTHER

Sponsor Role: lead

Responsible Party

prof. dr. Paul Dendale

prof. dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Renee De Busser, student

Role: STUDY_CHAIR

Hasselt University

Anika Nys, student

Role: STUDY_CHAIR

Hasselt University

Paul Dendale, prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Jessa Hospital

Locations

Jessa Ziekenhuis

Hasselt, , Belgium

Countries

Belgium

Other Identifiers

CVDIABMEL-1

Identifier Type: -

Identifier Source: org_study_id