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

• Conditions: Diabetic Neuropathies; Diabetes Mellitus, Type 2; Polyneuropathy Diabetes; Autonomic Neuropathy; Diabetic Complications Neurological

• Registration Number: NCT04208295
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2019-05
• Study Start: 2019-05-01
• Study First Submitted: 2019-12-19
• Study First Submitted QC: 2019-12-19
• Last Update Submitted: 2019-12-19
• Study First Posted: 2019-12-23
• Last Update Posted: 2019-12-23
• Primary Completion: 2020-06
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Type 2 diabetes
• Normal 12-lead ECG

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Danish Pain Research Center, Aarhus University Hospital; 🇩🇰 Aarhus, Skejby, Denmark