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Autonomic Cardiovascular Neuropathy in Recently Diagnosed DM2 Patients (ACNDM2)

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02931773
Acronym
ACNDM2
Enrollment
60
Registered
2016-10-13
Start date
2016-08-31
Completion date
2017-12-31
Last updated
2016-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysautonomia

Keywords

Diabetes Autonomic Cardiovascular

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.

Interventions

DEVICETask Force® Monitor

A head up tilt test carried out with a Task Force monitoring system

Sponsors

Instituto Nacional de Cardiologia Ignacio Chavez
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Sympathetic hyperactivity in recently diagnosed DM2 patientsone yearto show that there is a cardiovascular sympathetic hyperactivity by the time of the initial treatment

Countries

Mexico

Contacts

Primary ContactManuel A Sierra-Beltrán, Dr
manuel.sierra-beltran96@alumni.imperial.ac.uk00525556557059
Backup ContactAntonio J González-Hermosillo, Dr
sincope39@yahoo.com.mx00525556557059

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026