Autonomic Cardiovascular Neuropathy in Recently Diagnosed DM2 Patients (ACNDM2) (ACNDM2)
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ClinicalTrials.gov Identifier: NCT02931773 |
Recruitment Status : Unknown
Verified October 2016 by Manuel A Sierra Beltran, Instituto Nacional de Cardiologia Ignacio Chavez.
Recruitment status was: Recruiting
First Posted : October 13, 2016
Last Update Posted : October 13, 2016
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Condition or disease | Intervention/treatment |
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Dysautonomia | Device: Task Force® Monitor |
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 Type : | Observational |
Estimated Enrollment : | 60 participants |
Observational Model: | Case Control |
Time Perspective: | Prospective |
Official Title: | Autonomic Cardiovascular Neuropathy in Recently Diagnosed DM2 Patients and in Pre-Diabetes Patients |
Study Start Date : | August 2016 |
Estimated Primary Completion Date : | July 2017 |
Estimated Study Completion Date : | December 2017 |

Group/Cohort | Intervention/treatment |
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Control
Probands having normal fasting glucose and having a head up tilt test with Task Force® Monitor.
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Device: Task Force® Monitor
A head up tilt test carried out with a Task Force monitoring system |
Pre-Diabetes
Patients having normal fasting glucose and abnormal Oral Glucose tolerance test and having a head up tilt test with Task Force® Monitor.
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Device: Task Force® Monitor
A head up tilt test carried out with a Task Force monitoring system |
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
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Device: Task Force® Monitor
A head up tilt test carried out with a Task Force monitoring system |
- 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

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- patients who have not suffered Hypertension, Parkinson Diseae, Parkinsonic Syndrome, Guillain-Barré Disease, Myocardial Infarction, Obesity nor Ischemic Stroke
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02931773
Contact: Manuel A Sierra-Beltrán, Dr | 00525556557059 ext 1477 | manuel.sierra-beltran96@alumni.imperial.ac.uk | |
Contact: Antonio J González-Hermosillo, Dr | 00525556557059 ext 1477 | sincope39@yahoo.com.mx |
Mexico | |
Laboratio de Síncope | Recruiting |
Mexico City, DF, Mexico, 14080 | |
Contact: Manuel A Sierra-Beltrán, MD 00525556557059 ext 1477 manuel.sierra-beltran96@alumni.imperial.ac.uk | |
Contact: Antonio González-Hermosillo, MD 00525556557059 ext 1477 sincope39@yahoo.com.mx |
Principal Investigator: | Manuel A Sierra-Beltrán, MD | Instituto Nacional De Cardiología "Ignacio Chávez" |
Responsible Party: | Manuel A Sierra Beltran, Clinical Researcher, Instituto Nacional de Cardiologia Ignacio Chavez |
ClinicalTrials.gov Identifier: | NCT02931773 History of Changes |
Other Study ID Numbers: |
19677 |
First Posted: | October 13, 2016 Key Record Dates |
Last Update Posted: | October 13, 2016 |
Last Verified: | October 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | By publishing results as on as a paper on a Medical Journal |
Diabetes Autonomic Cardiovascular |
Primary Dysautonomias Autonomic Nervous System Diseases Nervous System Diseases |