Diabetes Mellitus, Type 1NCT03481374
Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes Mellitus.
A study testing autonomic function testing in people with Diabetes Mellitus, Type 1, run by Hasselt University at 1 site in Belgium.
Trial summary
testing of autonomic function and relationship with exercise and Qol in diabetic patients and controls Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- autonomic function testing
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jul 2016to 31 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- Antidepressants
- Non-catecholamines
- (anti) cholinergic medication
Trial locations and contacts
1 site in 1 country.
About this study
testing of autonomic function and relationship with exercise and Qol in diabetic patients and controls
Read the 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
- Being tested
- autonomic function testing
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autonomic function testingDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| subjects with Type 1 Diabetes mellitus | Active comparator | Type 1 diabetes patients without cardiovascular disease undergo autonomic function testing Receives: Diagnostic Test: autonomic function testing |
| Healthy controls | Placebo comparator | healthy people without known disease undergo autonomic function testing Receives: Diagnostic Test: autonomic function testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2 max
peak oxygen consumption
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start1 Jul 2016
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Jessa Hospital
- Responsible party
- Principal investigator, prof. dr. Paul Dendale, Hasselt University
- Investigators
- Renee De Busser, student, Study chair, Hasselt UniversityAnika Nys, student, Study chair, Hasselt UniversityPaul Dendale, prof. dr., Principal investigator, Jessa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03481374
- Sponsor's protocol ID
- CVDIABMEL-1
- Status last verified
- Apr 2018
- First submitted
- 22 Mar 2018
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Autonomic Neuropathy in Patients With Type 1 Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT03481374
- Acronym / sponsor ID
- CVDIABMEL-1
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Jessa Hospital
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 29 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| subjects with Type 1 Diabetes mellitus | Active comparator | Diagnostic Test: autonomic function testingType 1 diabetes patients without cardiovascular disease undergo autonomic function testing |
| Healthy controls | Placebo comparator | Diagnostic Test: autonomic function testinghealthy people without known disease undergo autonomic function testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (9 listed)
- Uncontrolled hypertension, atrial fibrillation and other cardiovascular conditions
- Severe lung disease
- Muscle deficiency
- Medication with influence on the autonomic nervous system:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| autonomic function testingautonomic 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 | Diagnostic test | Healthy controls, subjects with Type 1 Diabetes mellitus |
Primary outcome
VO2 max
Time frame: day 1
peak oxygen consumption
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renee De Busser, student study chair
Hasselt University
Anika Nys, student study chair
Hasselt University
Paul Dendale, prof. dr. principal investigator
Jessa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing autonomic function testing in people with Diabetes Mellitus, Type 1, run by Hasselt University at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2 max (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.