Autonomic Cardiovascular Neuropathy in Recently Diagnosed DM2 Patients (ACNDM2)

NCT02931773 | Unknown DMC

• 1 other identifier: 19677
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysautonomia

Keywords

Diabetes Autonomic Cardiovascular

Outcome Measures

Primary Outcomes (1)

• Sympathetic hyperactivity in recently diagnosed DM2 patients

  to show that there is a cardiovascular sympathetic hyperactivity by the time of the initial treatment

  one year

Study Arms (3)

Control

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

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.

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

Device: Task Force® Monitor

Interventions

Task Force® Monitor DEVICE

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

Control; Pre-Diabetes; Recently diagnosed Diabetic patients

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Those patients included as the cohorts of the GEA registry

You may qualify if:

• patients who have not suffered Hypertension, Parkinson Diseae, Parkinsonic Syndrome, Guillain-Barré Disease, Myocardial Infarction, Obesity nor Ischemic Stroke

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Nacional de Cardiologia Ignacio Chavez: lead

Study Sites (1)

Laboratio de Síncope

Mexico City, Mexico City, 14080, Mexico

RECRUITING

MeSH Terms

Conditions

Autonomic Nervous System Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

• Manuel A Sierra-Beltrán, MD

  Instituto Nacional De Cardiología "Ignacio Chávez"

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manuel A Sierra-Beltrán, Dr

CONTACT

00525556557059; manuel.sierra-beltran96@alumni.imperial.ac.uk

Antonio J González-Hermosillo, Dr

CONTACT

00525556557059; sincope39@yahoo.com.mx

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Researcher

Study Record Dates

• First Submitted: September 29, 2016
• First Posted: October 13, 2016
• Study Start: August 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: December 1, 2017
• Last Updated: October 13, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

ME (1)