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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Parkinson's Disease - Autonomic Dysregulation

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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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 |