Orthostatic Dysregulation and Associated Gastrointestinal Dysfunction in Parkinson's Disease - Evolution

Orthostatic Dysregulation and Associated Gastrointestinal Dysfunction in Parkinson's Disease - Evolution A Monocentric Study to Investigate the Development of Symptoms of Autonomic Dysregulation in Parkinson's Disease

Symptoms of blood pressure dysregulation, impaired swallowing and digestion are common amongst parkinson patients. The overall aim of this study is to examine blood pressure regulation and esophageal motility and gastric emptying in Parkinson's disease (PD) patients.

The investigators hypothesize that - compared to age-matched controls - PD patients display an altered regulation of blood pressure, altered gastroesophageal motility, and delayed gastric emptying. These symptoms occur already early in the disease process, but aggravate with progression of the disease.

The investigators will perform a 7-day blood pressure measurement, measurement of central blood pressure and pulse wave velocity, assessment of pulse variability, Schellong tests to assess orthostatic function, high resolution manometry assessments during swallowing acts, and a 13C-sodium octanoate breath test to assess gastric emptying, in 18 PD patients (9 each Hoehn&Yahr stages 1,2) and 12 age- and gender-matched healthy controls. Results will be interpreted in relation to the severity of PD motor symptoms.

The investigators anticipate that blood pressure dysregulation and gastroesophageal motility disturbances will be present only in PD subjects, but not in matched controls without neurological disorders and without any extrapyramidal motor signs. Furthermore, the investigators expect to find an association between motor impairment and the severity of these autonomic symptoms, however, that according to the Braak staging, subtle disturbances must already be present in the early stages of PD.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease - Autonomic Dysregulation

• Study Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

• Switzerland
  • ZH
    • Zurich, ZH, Switzerland, 8091
      • University Hospital Zurich, Neurology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects included in this trial must fulfil the he following criteria:

• informed, written & formal consent for participation

• male / female subjects, aged 50-70 years

  18 PD patients

• 9 subjects Hoehn & Yahr stage 1, disease duration <4 years

• 9 subjects Hoehn & Yahr stage 2; disease duration 4-8 years

  12 healthy control subjects

• age- and gender-matched
• without signs or history of neurological disorders
• without significant systemic comorbidities (malignant / cardiovascular)

Description

Inclusion criteria: - informed, written & formal consent for participation

• male/female subjects, aged 50-70 years
• PD patients (9 subjects each in Hoehn & Yahr stage 1 & 2)

Exclusion criteria: - Antihypertensive treatment

• medication influencing gastrointestinal motility for at least the elimination half life of the drug
• medication interfering with blood-pressure regulation for at least the elimination half life of the drug
• significant systemic illness
• BMI < 18 or > 30kg/m2
• symptoms or a history of GI disease or surgery
• with any evidence of infectious disease
• evidence or history of drug or alcohol abuse
• diabetes mellitus

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
orthostatic hypotension	drop of systolic (≥20mmHg) or diastolic (≥10mmHg) blood pressure upon Schellong test	during study visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
delayed gastric emptying	statistical difference in mean gastric emptying assessed via octanoate breath test	during study visit
long term blood pressure	mean 7d systolic, diastolic, mean arterial blood pressure and heart rate recordings	during 7d after study visit at home
heart rate variability	difference in heart rate variability or spectral analysis of heart rate variability?	during study visit
arterial stiffening	difference in pulse wave velocity and augmentation index calculation from applanation tonometry recordings?	during study visit
oesophageal motility	high-density manometry to measure aspects of oesophageal motility	during study visit
subjective symptoms of gastrointestinal and cardiovascular dysfunction	validated questionnaires: Fraser, 2007, p14133; Stanghellini, 1996, p14183; Revicki, 2003, p13823; Kaufmann, 2012, p13817; }	during study visit
Clinical assessment	UPDRS part III and MoCA score (Nasreddine, 2005, p14186)	during study visit

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Christian Baumann, Ass. Prof., MD, University Hospital Zurich, Neurology

Publications and helpful links

General Publications

• Epprecht L, Schreglmann SR, Goetze O, Woitalla D, Baumann CR, Waldvogel D. Unchanged gastric emptying and visceral perception in early Parkinson's disease after a high caloric test meal. J Neurol. 2015 Aug;262(8):1946-53. doi: 10.1007/s00415-015-7799-z. Epub 2015 Jun 6.

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (ACTUAL): December 1, 2013
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: January 17, 2012
• First Submitted That Met QC Criteria: January 23, 2012
• First Posted (ESTIMATE): January 26, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): September 30, 2015
• Last Update Submitted That Met QC Criteria: September 29, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Primary Dysautonomias; Autonomic Nervous System Diseases
• Other Study ID Numbers: KEK-ZH-NR. 2011-0077