NCT03481374

Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes Mellitus.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Hasselt University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-03-31
• Completion: 2017-03-31
• First posted: 2018-03-29
• Last updated: 2018-04-17

Locations

1 site across 1 country: Belgium