Autonomic Cardiovascular Neuropathy in Recently Diagnosed DM2 Patients (ACNDM2) (ACNDM2)

October 12, 2016 updated by: Manuel A Sierra Beltran, Instituto Nacional de Cardiologia Ignacio Chavez

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Those patients included as the cohorts of the GEA registry

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Cardiologia Ignacio Chavez

Investigators

  • Principal Investigator: Manuel A Sierra-Beltrán, MD, Instituto Nacional de Cardiología "Ignacio Chávez"

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

September 29, 2016

First Submitted That Met QC Criteria

October 12, 2016

First Posted (Estimate)

October 13, 2016

Study Record Updates

Last Update Posted (Estimate)

October 13, 2016

Last Update Submitted That Met QC Criteria

October 12, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19677

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

By publishing results as on as a paper on a Medical Journal

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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