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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02931773
Recruitment Status : Unknown
Verified October 2016 by Manuel A Sierra Beltran, Instituto Nacional de Cardiologia Ignacio Chavez.
Recruitment status was:  Recruiting
First Posted : October 13, 2016
Last Update Posted : October 13, 2016
Sponsor:
Information provided by (Responsible Party):
Manuel A Sierra Beltran, Instituto Nacional de Cardiologia Ignacio Chavez

Tracking Information
First Submitted Date September 29, 2016
First Posted Date October 13, 2016
Last Update Posted Date October 13, 2016
Study Start Date August 2016
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 12, 2016)
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 Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Autonomic Cardiovascular Neuropathy in Recently Diagnosed DM2 Patients (ACNDM2)
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 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
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Those patients included as the cohorts of the GEA registry
Condition Dysautonomia
Intervention Device: Task Force® Monitor
A head up tilt test carried out with a Task Force monitoring system
Study Groups/Cohorts
  • Control
    Probands having normal fasting glucose and having a head up tilt test with Task Force® Monitor.
    Intervention: Device: Task Force® Monitor
  • Pre-Diabetes
    Patients having normal fasting glucose and abnormal Oral Glucose tolerance test and having a head up tilt test with Task Force® Monitor.
    Intervention: Device: Task Force® Monitor
  • 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
    Intervention: Device: Task Force® Monitor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: October 12, 2016)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2017
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Mexico
Removed Location Countries  
 
Administrative Information
NCT Number NCT02931773
Other Study ID Numbers 19677
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: By publishing results as on as a paper on a Medical Journal
Responsible Party Manuel A Sierra Beltran, Instituto Nacional de Cardiologia Ignacio Chavez
Study Sponsor Instituto Nacional de Cardiologia Ignacio Chavez
Collaborators Not Provided
Investigators
Principal Investigator: Manuel A Sierra-Beltrán, MD Instituto Nacional De Cardiología "Ignacio Chávez"
PRS Account Instituto Nacional de Cardiologia Ignacio Chavez
Verification Date October 2016