Autonomic Cardiovascular Neuropathy in Recently Diagnosed DM2 Patients (ACNDM2)

Dysautonomia Clinical Trial

— ACNDM2  

Official title:

Autonomic Cardiovascular Neuropathy in Recently Diagnosed DM2 Patients and in Pre-Diabetes Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02931773
• Other study ID #: 19677
• Status: Recruiting
• Phase: N/A
• First received: September 29, 2016
• Last updated: October 12, 2016
• Start date: August 2016
• Est. completion date: December 2017

Study information

• Verified date: October 2016
• Source: Instituto Nacional de Cardiologia Ignacio Chavez
• Contact: Manuel A Sierra-Beltrán, Dr
• Phone: 00525556557059
• Email: manuel.sierra-beltran96[@]alumni.imperial.ac.uk
• Is FDA regulated: No
• Health authority: Mexico: National Health Institutes and High Specialties Hospital Coordination Commision
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Autonomic Nervous System Diseases
• Dysautonomia
• Primary Dysautonomias

Intervention

Device:
• Task Force® Monitor
A head up tilt test carried out with a Task Force monitoring system

Locations

Country	Name	City	State
Mexico	Laboratio de Síncope	Mexico City	DF

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Cardiologia Ignacio Chavez

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes