- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04208295
24-hour Blood Pressure Dynamics and Autonomic Adrenergic Regulation in Type 2 Diabetics
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.
Study Overview
Status
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Skejby
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Aarhus, Skejby, Denmark, 8200
- Danish Pain Research Center, Aarhus University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Patients
Type 2 diabetics
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Healthy controls
Matched healthy controls
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
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24 hour Blood Pressure
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Day/night blood pressure ratio.
Day time standard deviation and average real time variation
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Autonomic adrenergic measure
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Valsalva maneuver - Phase 2Late, Pressure recovery time, Baroreceptor sensitivity, Phase 4 rise.
Head up tilt test - Blood pressure dip ratio
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IDNC_Adrenergic_BP_Testing
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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