Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes Mellitus.

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes Mellitus.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03481374
• Other study ID #: CVDIABMEL-1
• Status: Completed
• Phase: N/A
• First received: March 22, 2018
• Last updated: April 14, 2018
• Start date: July 1, 2016
• Est. completion date: March 31, 2017

Study information

• Verified date: April 2018
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: March 31, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
Belgium	Jessa Ziekenhuis	Hasselt

Sponsors (2)

Lead Sponsor	Collaborator
Hasselt University	Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VO2 max	peak oxygen consumption	day 1