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

Completed

• Conditions: Parkinson's Disease - Autonomic Dysregulation

• Registration Number: NCT01518751
• Lead Sponsor: University of Zurich

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-01-17
• Study First Submitted QC: 2012-01-23
• Study First Posted: 2012-01-26
• Primary Completion: 2013-12
• Study Completion: 2014-12
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-29
• Last Update Posted: 2015-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
orthostatic hypotension	during study visit	drop of systolic (≥20mmHg) or diastolic (≥10mmHg) blood pressure upon Schellong test

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Zurich, Neurology; 🇨🇭 Zurich, ZH, Switzerland