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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-01

Study Completion Date

2021-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients

Type 2 diabetics

No interventions assigned to this group

Healthy controls

Matched healthy controls

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Locations

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Danish Pain Research Center, Aarhus University Hospital

Aarhus, Skejby, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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IDNC_Adrenergic_BP_Testing

Identifier Type: -

Identifier Source: org_study_id