- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03481374
Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes Mellitus.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Hasselt, Belgium, 3500
- Jessa Ziekenhuis
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: subjects with Type 1 Diabetes mellitus
Type 1 diabetes patients without cardiovascular disease undergo autonomic function testing
|
autonomic function testing, ergospirometry, three questionnaires Other Names:
|
Placebo Comparator: Healthy controls
healthy people without known disease undergo autonomic function testing
|
autonomic function testing, ergospirometry, three questionnaires Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VO2 max
Time Frame: day 1
|
peak oxygen consumption
|
day 1
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Paul Dendale, prof. dr., Jessa hospital
- Study Chair: Renee De Busser, student, Hasselt University
- Study Chair: Anika Nys, student, Hasselt University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CVDIABMEL-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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