Autonomic Cardiovascular Neuropathy in Recently Diagnosed DM2 Patients (ACNDM2)

• Conditions: Dysautonomia
• Interventions: Device: Task Force® Monitor

• Registration Number: NCT02931773
• Lead Sponsor: Instituto Nacional de Cardiologia Ignacio Chavez

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.

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 Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-09-29
• Status Verified: 2016-10
• Study First Submitted QC: 2016-10-12
• Last Update Submitted: 2016-10-12
• Study First Posted: 2016-10-13
• Last Update Posted: 2016-10-13
• Primary Completion: 2017-07
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Task Force® Monitor	Probands having normal fasting glucose and having a head up tilt test with Task Force® Monitor.
Pre-Diabetes	Task Force® Monitor	Patients having normal fasting glucose and abnormal Oral Glucose tolerance test and having a head up tilt test with Task Force® Monitor.
Recently diagnosed Diabetic patients	Task Force® Monitor	Patients being diagnosed as Diabetics type in the recent five years and having a head up tilt test with Task Force® Monitor

Primary Outcome Measures

Name	Time	Method
Sympathetic hyperactivity in recently diagnosed DM2 patients	one year	to show that there is a cardiovascular sympathetic hyperactivity by the time of the initial treatment

Trial Locations

Locations (1)

Laboratio de Síncope; 🇲🇽 Mexico City, DF, Mexico