Autonomic Cardiovascular Neuropathy in Recently Diagnosed DM2 Patients (ACNDM2)

NCT ID: NCT02931773

Last Updated: 2016-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-31

Study Completion Date

2017-12-31

Brief Summary

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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

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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

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Dysautonomia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Control

Probands having normal fasting glucose and having a head up tilt test with Task Force® Monitor.

Task Force® Monitor

Intervention Type DEVICE

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.

Task Force® Monitor

Intervention Type DEVICE

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

Task Force® Monitor

Intervention Type DEVICE

A head up tilt test carried out with a Task Force monitoring system

Interventions

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Task Force® Monitor

A head up tilt test carried out with a Task Force monitoring system

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto Nacional de Cardiologia Ignacio Chavez

OTHER

Sponsor Role lead

Responsible Party

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Manuel A Sierra Beltran

Clinical Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manuel A Sierra-Beltrán, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional De Cardiología "Ignacio Chávez"

Locations

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Laboratio de Síncope

Mexico City, Mexico City, Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Manuel A Sierra-Beltrán, Dr

Role: CONTACT

00525556557059 ext. 1477

Antonio J González-Hermosillo, Dr

Role: CONTACT

00525556557059 ext. 1477

Facility Contacts

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Manuel A Sierra-Beltrán, MD

Role: primary

00525556557059 ext. 1477

Antonio González-Hermosillo, MD

Role: backup

00525556557059 ext. 1477

Other Identifiers

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19677

Identifier Type: -

Identifier Source: org_study_id

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