Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes Mellitus.
1 other identifier
interventional
79
1 country
1
Brief Summary
testing of autonomic function and relationship with exercise and Qol in diabetic patients and controls
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2017
CompletedFirst Submitted
Initial submission to the registry
March 22, 2018
CompletedFirst Posted
Study publicly available on registry
March 29, 2018
CompletedApril 17, 2018
April 1, 2018
9 months
March 22, 2018
April 14, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
VO2 max
peak oxygen consumption
day 1
Study Arms (2)
subjects with Type 1 Diabetes mellitus
ACTIVE COMPARATORType 1 diabetes patients without cardiovascular disease undergo autonomic function testing
Healthy controls
PLACEBO COMPARATORhealthy people without known disease undergo autonomic function testing
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hasselt Universitylead
- Jessa Hospitalcollaborator
Study Sites (1)
Jessa Ziekenhuis
Hasselt, 3500, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Renee De Busser, student
Hasselt University
- STUDY CHAIR
Anika Nys, student
Hasselt University
- PRINCIPAL INVESTIGATOR
Paul Dendale, prof. dr.
Jessa Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- prof. dr.
Study Record Dates
First Submitted
March 22, 2018
First Posted
March 29, 2018
Study Start
July 1, 2016
Primary Completion
March 31, 2017
Study Completion
March 31, 2017
Last Updated
April 17, 2018
Record last verified: 2018-04