Diabetes Mellitus, Type 1NCT03930004
Preclinical Cardiomyopathy and Autonomic Function in Type 1 Diabetes
An observational study of Diabetes Mellitus, Type 1 and Diabetic Cardiomyopathies, run by Roberto Léo da Silva at 1 site in Brazil.
Trial summary
Type 1 diabetes mellitus is a chronic autoimmune disease, associated with an increased risk of cardiovascular diseases. The development of cardiomyopathy in type 1 diabetes, independent of hypertension and coronary heart disease, is still controversial. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 1, Diabetic Cardiomyopathies, Autonomic Neuropathy, Diabetic
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 6 Jul 2018to 1 Sep 2019
- Phase
- Observational
- 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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Selection of patients from a tertiary hospital.
Who may be able to join
- type 1 diabetes mellitus
Who cannot join
- hypertension
- coronary artery disease
- heart valve disease
- ventricular dysfunction
- radiotherapy or chemotherapy
- alcoholism
- limited acoustic window
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preclinical Cardiomyopathy in Type 1 Diabetes: Correlation With Autonomic Dysfunction
Type 1 diabetes mellitus is a chronic autoimmune disease, associated with an increased risk of cardiovascular diseases. The development of cardiomyopathy in type 1 diabetes, independent of hypertension and coronary heart disease, is still controversial. A possible mechanism for diabetic cardiomyopathy is autonomic dysfunction. This study aims to evaluate cardiac function and structure, and to relate them with autonomic dysfunction in type 1 diabetes.
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetic Cardiomyopathies, Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Type 1 diabetic patients | Patients diagnosed with type 1 diabetes mellitus with criteria for cardiovascular autonomic neuropathy, asymptomatic, normotensive, with negative medical history of cardiovascular disease. Transthoracic echocardiography, including: tissue Doppler indices of diastolic filling and speckle tracking for systolic and diastolic strain/strain rate, exclusion of valvular abnormalities, assessment of heart structure and function. | |
| Control - Healthy subjects | Fifteen age- and sex-matched healthy control subjects, asymptomatic, normotensive, with negative medical history of cardiovascular disease. Transthoracic echocardiography, including: tissue Doppler indices of diastolic filling and speckle tracking for systolic and diastolic strain/strain rate, exclusion of valvular abnormalities, assessment of heart structure and function. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preclinical myocardial dysfunction
Incidence of patients with alteration in left ventricular myocardial strain (≤ 17% in absolute value).
Measured: At patient inclusion.
Left ventricular diastolic dysfunction
Incidence of patients with signs of diastolic dysfunction: average E/e' ratio (abnormal when > 14)
Measured: At patient inclusion.
Left ventricular hypertrophy
Incidence of patients with LV mass by linear measurements > 95 g/m2 if women and > 115 g/m2 if men.
Measured: At patient inclusion.
Left atrial dysfunction
Incidence of patients with abnormal reservoir strain (normal range: 38%-41%), or abnormal conduit strain (normal range: 21%-25%), or abnormal contractile strain (normal range: 16%-19%).
Measured: At patient inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start6 Jul 2018
- Primary completion1 Aug 2019
- Study completion1 Sep 2019
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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roberto Léo da Silva
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Roberto Léo da Silva, Instituto de Cardiologia de Santa Catarina
- Investigators
- Thais R Weber, MD, Study chair, HU/UFSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03930004
- Sponsor's protocol ID
- HU-UFSC 2018
- Status last verified
- Oct 2019
- First submitted
- 14 Feb 2019
- Last updated
- 8 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preclinical Cardiomyopathy in Type 1 Diabetes: Correlation With Autonomic Dysfunction
- ClinicalTrials.gov ID
- NCT03930004
- Acronym / sponsor ID
- HU-UFSC 2018
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Roberto Léo da SilvaUniversity, hospital or other
- Study start
- 6 Jul 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 29 Apr 2019 (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.
Type 1 diabetes mellitus is a chronic autoimmune disease, associated with an increased risk of cardiovascular diseases. The development of cardiomyopathy in type 1 diabetes, independent of hypertension and coronary heart disease, is still controversial. A possible mechanism for diabetic cardiomyopathy is autonomic dysfunction. This study aims to evaluate cardiac function and structure, and to relate them with autonomic dysfunction in type 1 diabetes.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 1 diabetic patients | – | –Patients diagnosed with type 1 diabetes mellitus with criteria for cardiovascular autonomic neuropathy, asymptomatic, normotensive, with negative medical history of cardiovascular disease. Transthoracic echocardiography, including: tissue Doppler indices of diastolic filling and speckle tracking for systolic and diastolic strain/strain rate, exclusion of valvular abnormalities, assessment of heart structure and function. |
| Control - Healthy subjects | – | –Fifteen age- and sex-matched healthy control subjects, asymptomatic, normotensive, with negative medical history of cardiovascular disease. Transthoracic echocardiography, including: tissue Doppler indices of diastolic filling and speckle tracking for systolic and diastolic strain/strain rate, exclusion of valvular abnormalities, assessment of heart structure and function. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Selection of patients from a tertiary hospital.
Key inclusion criteria (1 listed)
- type 1 diabetes mellitus
Key exclusion criteria (7 listed)
- hypertension
- coronary artery disease
- heart valve disease
- ventricular dysfunction
- radiotherapy or chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Preclinical myocardial dysfunction
Time frame: At patient inclusion.
Incidence of patients with alteration in left ventricular myocardial strain (≤ 17% in absolute value).
Left ventricular diastolic dysfunction
Time frame: At patient inclusion.
Incidence of patients with signs of diastolic dysfunction: average E/e' ratio (abnormal when > 14)
Left ventricular hypertrophy
Time frame: At patient inclusion.
Incidence of patients with LV mass by linear measurements > 95 g/m2 if women and > 115 g/m2 if men.
Left atrial dysfunction
Time frame: At patient inclusion.
Incidence of patients with abnormal reservoir strain (normal range: 38%-41%), or abnormal conduit strain (normal range: 21%-25%), or abnormal contractile strain (normal range: 16%-19%).
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 8 Oct 2019.
- Individual participant dataSharing planned: No
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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.
Thais R Weber, MD study chair
HU/UFSC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1 and Diabetic Cardiomyopathies, run by Roberto Léo da Silva at 1 site in Brazil.
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 1 inclusion and 7 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 8 Oct 2019. 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 Brazil. 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. 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?
Preclinical myocardial dysfunction (time frame: At patient inclusion.). The study lists 4 primary outcomes in all. 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 8 Oct 2019.