Autonomic Cardiovascular Neuropathy in Recently Diagnosed DM2 Patients (ACNDM2)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dysautonomia

Intervention / Treatment
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* Device: Task Force® Monitor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>Probands having normal fasting glucose and having a head up tilt test with Task Force® Monitor. | Device: Task Force® Monitor<br>* A head up tilt test carried out with a Task Force monitoring system<br>|
| Pre-Diabetes<br>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<br>* A head up tilt test carried out with a Task Force monitoring system<br>|
| Recently diagnosed Diabetic patients<br>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<br>* A head up tilt test carried out with a Task Force monitoring system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Autonomic Cardiovascular