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24-hour Blood Pressure Dynamics and Autonomic Adrenergic Regulation in Type 2 Diabetics

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: NCT04208295
Recruitment Status : Enrolling by invitation
First Posted : December 23, 2019
Last Update Posted : December 23, 2019
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:

Autonomic neuropathy is a common complication of type 2 diabetes mellitus. Symptoms from cardiovascular autonomic neuropathy include, dizziness, orthostatic hypotension and insufficient heart rate and blood pressure (BP) regulation during physical exertion. The degree of cardiovascular autonomic neuropathy is most commonly measured as cardiac autonomic neuropathy based on at least two abnormal cardiac reflex tests, which primarily measures parasympathetic indices of the autonomic nervous system (ANS).

Few measures are available for quantifying the sympathetic/adrenergic branch of the ANS.

Circadian changes in BP is a documented measure of BP variability, regulated centrally by a multitude of centers. A growing number of studies indicate that a diminished BP variability is associated with increased cardiovascular risk and injury. The ANS plays a pivotal role in the execution of these circadian BP changes, mainly through sympathetic adrenergic nerve fibers

Few studies have investigated the applicability of 24-hour indices as predictor for autonomic adrenergic dysfunction. No previous studies have investigated the association between clinical markers of adrenergic function, and 24-hour blood pressure indices in type 2 diabetes.


Condition or disease
Diabetes Mellitus, Type 2 Polyneuropathy Diabetes Autonomic Neuropathy Diabetic Neuropathies Diabetic Complications Neurological

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: 24-hour Blood Pressure Dynamics and Autonomic Adrenergic Regulation in Type 2 Diabetics
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2021

Group/Cohort
Patients
Type 2 diabetics
Healthy controls
Matched healthy controls



Primary Outcome Measures :
  1. 24 hour Blood Pressure [ Time Frame: 0 ]
    Day/night blood pressure ratio. Day time standard deviation and average real time variation

  2. Autonomic adrenergic measure [ Time Frame: 0 ]
    Valsalva maneuver - Phase 2Late, Pressure recovery time, Baroreceptor sensitivity, Phase 4 rise. Head up tilt test - Blood pressure dip ratio



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Type 2 diabetics previously screened for diabetic polyneuropathy will be invited
Criteria

Inclusion Criteria:

  • Type 2 diabetes
  • Normal 12-lead ECG

Exclusion Criteria:

  • Significant cardiovascular, muscular, lung, kidney or psychiatric disease
  • Pregnancy
  • Malignant disease, HIV, alcoholism or drug abuse
  • Parkinson disease
  • Ischemic heart disease
  • Vital medicine that can affect the autonomic nervous system

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04208295


Locations
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Denmark
Danish Pain Research Center, Aarhus University Hospital
Aarhus, Skejby, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT04208295    
Other Study ID Numbers: IDNC_Adrenergic_BP_Testing
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: December 23, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetic Neuropathies
Polyneuropathies
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Complications
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases