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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
Sponsor:
Information provided by (Responsible Party):
Manuel A Sierra Beltran, Instituto Nacional de Cardiologia Ignacio Chavez

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Dysautonomia Device: Task Force® Monitor

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
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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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Control
Probands having normal fasting glucose and having a head up tilt test with Task Force® Monitor.
 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.
 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
 Device: Task Force® Monitor
A head up tilt test carried out with a Task Force monitoring system


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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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
Study Population
Those patients included as the cohorts of the GEA registry
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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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

Locations
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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   
Sponsors and Collaborators
Instituto Nacional de Cardiologia Ignacio Chavez
Investigators
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Principal Investigator: Manuel A Sierra-Beltrán, MD Instituto Nacional De Cardiología "Ignacio Chávez"
More Information
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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
Keywords provided by Manuel A Sierra Beltran, Instituto Nacional de Cardiologia Ignacio Chavez:
Diabetes Autonomic Cardiovascular
Additional relevant MeSH terms:
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Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases