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NCT04208295 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04208295
Other study ID # IDNC_Adrenergic_BP_Testing
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date May 1, 2019
Est. completion date June 2021

Study information
Verified date May 2019
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 80
Est. completion date June 2021
Est. primary completion date June 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark Danish Pain Research Center, Aarhus University Hospital Aarhus Skejby

Sponsors (1)
Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

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