Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes Mellitus.
Primary Purpose
Diabetes Mellitus, Type 1
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
autonomic function testing
Sponsored by
About this trial
This is an interventional screening trial for Diabetes Mellitus, Type 1
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
Sites / Locations
- Jessa Ziekenhuis
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
subjects with Type 1 Diabetes mellitus
Healthy controls
Arm Description
Type 1 diabetes patients without cardiovascular disease undergo autonomic function testing
healthy people without known disease undergo autonomic function testing
Outcomes
Primary Outcome Measures
VO2 max
peak oxygen consumption
Secondary Outcome Measures
Full Information
NCT ID
NCT03481374
First Posted
March 22, 2018
Last Updated
April 14, 2018
Sponsor
Hasselt University
Collaborators
Jessa Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03481374
Brief Title
Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes Mellitus.
Official Title
Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes Mellitus.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
March 31, 2017 (Actual)
Study Completion Date
March 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
Jessa Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
subjects with Type 1 Diabetes mellitus
Arm Type
Active Comparator
Arm Description
Type 1 diabetes patients without cardiovascular disease undergo autonomic function testing
Arm Title
Healthy controls
Arm Type
Placebo Comparator
Arm Description
healthy people without known disease undergo autonomic function testing
Intervention Type
Diagnostic Test
Intervention Name(s)
autonomic function testing
Intervention Description
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
Primary Outcome Measure Information:
Title
VO2 max
Description
peak oxygen consumption
Time Frame
day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renee De Busser, student
Organizational Affiliation
Hasselt University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Anika Nys, student
Organizational Affiliation
Hasselt University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Paul Dendale, prof. dr.
Organizational Affiliation
Jessa Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jessa Ziekenhuis
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes Mellitus.
We'll reach out to this number within 24 hrs