Autonomic Cardiovascular Neuropathy in Recently Diagnosed DM2 Patients (ACNDM2)

National Institute of Cardiology Ignacio Chavez

Status: Unknown

Conditions: Dysautonomia

Treatments: Device: Task Force® Monitor

Study type: Observational

Funder types: Other

Identifiers

NCT02931773

19677

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

60 participants in 3 patient groups

Control

Description:

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

Treatment:

Device: Task Force® Monitor

Pre-Diabetes

Description:

Patients having normal fasting glucose and abnormal Oral Glucose tolerance test and having a head up tilt test with Task Force® Monitor.

Treatment:

Device: Task Force® Monitor

Recently diagnosed Diabetic patients

Description:

Patients being diagnosed as Diabetics type in the recent five years and having a head up tilt test with Task Force® Monitor

Treatment:

Device: Task Force® Monitor