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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04208295

Enrollment

Registered

2019-12-23

Start date

2019-05-01

Completion date

2021-06-30

Last updated

2019-12-23

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

Conditions

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
24 hour Blood Pressure	0	Day/night blood pressure ratio. Day time standard deviation and average real time variation
Autonomic adrenergic measure	0	Valsalva maneuver - Phase 2Late, Pressure recovery time, Baroreceptor sensitivity, Phase 4 rise. Head up tilt test - Blood pressure dip ratio

Countries

Denmark

Outcome results