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

NCT04208295 | Unknown DMC

• 1 other identifier: IDNC_Adrenergic_BP_Testing
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 24 hour Blood Pressure

  Day/night blood pressure ratio. Day time standard deviation and average real time variation

  0

• Autonomic adrenergic measure

  Valsalva maneuver - Phase 2Late, Pressure recovery time, Baroreceptor sensitivity, Phase 4 rise. Head up tilt test - Blood pressure dip ratio

  0

Study Arms (2)

Patients

Type 2 diabetics

Healthy controls

Matched healthy controls

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Type 2 diabetics previously screened for diabetic polyneuropathy will be invited

You may qualify if:

• Type 2 diabetes
• Normal 12-lead ECG

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Danish Pain Research Center, Aarhus University Hospital

Aarhus, Skejby, 8200, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: December 23, 2019
• Study Start: May 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2021
• Last Updated: December 23, 2019

Record last verified: 2019-05

Locations

DK (1)