Clinical Trial: Autonomic Cardiovascular Neuropathy in Recently Diagnosed DM2 Patients (ACNDM2)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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 Summary:

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.


Sponsor: Instituto Nacional de Cardiologia Ignacio Chavez

Current Primary Outcome: Sympathetic hyperactivity in recently diagnosed DM2 patients [ Time Frame: one year ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Instituto Nacional de Cardiologia Ignacio Chavez

Dates:
Date Received: September 29, 2016
Date Started: August 2016
Date Completion: December 2017
Last Updated: October 12, 2016
Last Verified: October 2016