24-hour Blood Pressure Dynamics and Autonomic Adrenergic Regulation in Type 2 Diabetics
|ClinicalTrials.gov Identifier: NCT04208295|
Recruitment Status : Enrolling by invitation
First Posted : December 23, 2019
Last Update Posted : December 23, 2019
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|
|Study Type :||Observational|
|Estimated Enrollment :||80 participants|
|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|
Type 2 diabetics
Matched healthy controls
- 24 hour Blood Pressure [ Time Frame: 0 ]Day/night blood pressure ratio. Day time standard deviation and average real time variation
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04208295
|Danish Pain Research Center, Aarhus University Hospital|
|Aarhus, Skejby, Denmark, 8200|