DysautonomiaACNDM2NCT02931773
Autonomic Cardiovascular Neuropathy in Recently Diagnosed DM2 Patients (ACNDM2)
An observational study of Dysautonomia, run by Instituto Nacional de Cardiologia Ignacio Chavez at 1 site in Mexico.
Trial summary
The investigators are studying the initial autonomic alterations in participants recently diagnosed with DM2 and in those patients classified as Pre-Diabetes, mainly focused on the baroreceptor sensitivity and on the peripheral sympathetic innervation. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dysautonomia
- What is being tested?
- Task Force® Monitor
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- Aug 2016to Dec 2017
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Those patients included as the cohorts of the GEA registry
Who may be able to join
- patients who have not suffered Hypertension, Parkinson Diseae, Parkinsonic Syndrome, Guillain-Barré Disease, Myocardial Infarction, Obesity nor Ischemic Stroke
Who cannot join
- Those older than 55 years old, or younger than 18 years old.
- Those who have suffered Hypertension, Parkinson Diseae, Parkinsonic Syndrome, Guillain-Barré Disease, Myocardial Infarction, Obesity or Ischemic Stroke
Trial locations and contacts
1 site in 1 country.
Manuel A Sierra-Beltrán, Dr contact
Mexico1 site, 1 recruiting
- Recruiting
Laboratio de Síncope
Mexico City, Mexico City, 14080
Manuel A Sierra-Beltrán, MD, 00525556557059 ext. 1477, manuel.sierra-beltran96@alumni.imperial.ac.uk
Antonio González-Hermosillo, MD, 00525556557059 ext. 1477, sincope39@yahoo.com.mx
About this study
Official title: Autonomic Cardiovascular Neuropathy in Recently Diagnosed DM2 Patients and in Pre-Diabetes Patients
The investigators are studying the initial autonomic alterations in participants recently diagnosed with DM2 and in those patients classified as Pre-Diabetes, mainly focused on the baroreceptor sensitivity and on the peripheral sympathetic innervation.
Read the detailed description
Until now the autonomic dysfunction in Diabetes Mellitus type 2 (DM2)has been broadly studied in long term patients. Thus, clinical features as cardiac autonomic neuropathy (CAN) and the lack of the baroreceptor reflex were widely described in patients with a long standing Diabetes. However, there hasn´t been a description of the initial autonomic imbalance in both Pre-Diabetes and recently diagnosed DM2 patients. This is the goal of the present research study, to assess the autonomic dysfunction among these sets of patients.
Yet CAN is finding mostly happening in late stages of DM2 and so the lack of Baroreceptor reflex sensitivity there are other subtle indicators of dysautonomia which hasn't been extensively analyzed. In fact, rest tachycardia and orthostatic intolerance may point to an early dysautonomia. A description of the impairment of the cardiovascular autonomic regulation is still missing. Therefore, the investigators intend to evaluate this regulation through the means of a Task Force System.
- Conditions
- Dysautonomia
- Being tested
- Task Force® Monitor
- Keywords
- Diabetes Autonomic Cardiovascular
- Medical subject headings
- Autonomic Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Task Force® MonitorDevice
A head up tilt test carried out with a Task Force monitoring system
| Study group | Role | What they receive |
|---|---|---|
| Control | Probands having normal fasting glucose and having a head up tilt test with Task Force® Monitor. Receives: Device: Task Force® Monitor | |
| Pre-Diabetes | Patients having normal fasting glucose and abnormal Oral Glucose tolerance test and having a head up tilt test with Task Force® Monitor. Receives: Device: Task Force® Monitor | |
| Recently diagnosed Diabetic patients | Patients being diagnosed as Diabetics type in the recent five years and having a head up tilt test with Task Force® Monitor Receives: Device: Task Force® Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sympathetic hyperactivity in recently diagnosed DM2 patients
to show that there is a cardiovascular sympathetic hyperactivity by the time of the initial treatment
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study startAug 2016
- Primary completionJul 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysautonomiaStudies 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
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cardiologia Ignacio Chavez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel A Sierra Beltran, Instituto Nacional de Cardiologia Ignacio Chavez
- Investigators
- Manuel A Sierra-Beltrán, MD, Principal investigator, Instituto Nacional De Cardiología "Ignacio Chávez"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02931773
- Sponsor's protocol ID
- 19677
- Acronym
- ACNDM2
- Status last verified
- Oct 2016
- First submitted
- 29 Sep 2016
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: By publishing results as on as a paper on a Medical Journal
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic Cardiovascular Neuropathy in Recently Diagnosed DM2 Patients and in Pre-Diabetes Patients
- ClinicalTrials.gov ID
- NCT02931773
- Acronym / sponsor ID
- ACNDM2 / 19677
- Conditions
- Dysautonomia
- Keywords
- Diabetes Autonomic Cardiovascular
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Instituto Nacional de Cardiologia Ignacio ChavezUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 13 Oct 2016 (estimated)
- 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.
The investigators are studying the initial autonomic alterations in participants recently diagnosed with DM2 and in those patients classified as Pre-Diabetes, mainly focused on the baroreceptor sensitivity and on the peripheral sympathetic innervation.
Detailed description
Until now the autonomic dysfunction in Diabetes Mellitus type 2 (DM2)has been broadly studied in long term patients. Thus, clinical features as cardiac autonomic neuropathy (CAN) and the lack of the baroreceptor reflex were widely described in patients with a long standing Diabetes. However, there hasn´t been a description of the initial autonomic imbalance in both Pre-Diabetes and recently diagnosed DM2 patients. This is the goal of the present research study, to assess the autonomic dysfunction among these sets of patients.
Yet CAN is finding mostly happening in late stages of DM2 and so the lack of Baroreceptor reflex sensitivity there are other subtle indicators of dysautonomia which hasn't been extensively analyzed. In fact, rest tachycardia and orthostatic intolerance may point to an early dysautonomia. A description of the impairment of the cardiovascular autonomic regulation is still missing. Therefore, the investigators intend to evaluate this regulation through the means of a Task Force System.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | – | Device: Task Force® MonitorProbands having normal fasting glucose and having a head up tilt test with Task Force® Monitor. |
| Pre-Diabetes | – | Device: Task Force® MonitorPatients having normal fasting glucose and abnormal Oral Glucose tolerance test and having a head up tilt test with Task Force® Monitor. |
| Recently diagnosed Diabetic patients | – | Device: Task Force® MonitorPatients being diagnosed as Diabetics type in the recent five years and having a head up tilt test with Task Force® Monitor |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Those patients included as the cohorts of the GEA registry
Key inclusion criteria (1 listed)
- patients who have not suffered Hypertension, Parkinson Diseae, Parkinsonic Syndrome, Guillain-Barré Disease, Myocardial Infarction, Obesity nor Ischemic Stroke
Key exclusion criteria (2 listed)
- Those older than 55 years old, or younger than 18 years old.
- Those who have suffered Hypertension, Parkinson Diseae, Parkinsonic Syndrome, Guillain-Barré Disease, Myocardial Infarction, Obesity or Ischemic Stroke
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 |
|---|---|---|
| Task Force® MonitorA head up tilt test carried out with a Task Force monitoring system | Device | Control, Pre-Diabetes, Recently diagnosed Diabetic patients |
Primary outcome
Sympathetic hyperactivity in recently diagnosed DM2 patients
Time frame: one year
to show that there is a cardiovascular sympathetic hyperactivity by the time of the initial treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2016.
- Individual participant dataSharing planned: Yes. By publishing results as on as a paper on a Medical Journal
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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.
Manuel A Sierra-Beltrán, Dr contact
Manuel A Sierra-Beltrán, MD principal investigator
Instituto Nacional De Cardiología "Ignacio Chávez"
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 Dysautonomia, run by Instituto Nacional de Cardiologia Ignacio Chavez at 1 site in Mexico.
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 2 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: status not confirmed, as of the sponsor's last update on 13 Oct 2016. 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 Mexico. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manuel A Sierra-Beltrán, Dr (00525556557059 ext. 1477, manuel.sierra-beltran96@alumni.imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sympathetic hyperactivity in recently diagnosed DM2 patients (time frame: one year). 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 13 Oct 2016.