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Orthostatic Dysregulation and Associated Gastrointestinal Dysfunction in Parkinson's Disease - Evolution
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Purpose
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.
| Condition |
|---|
| Parkinson`s Disease - Autonomic Dysregulation |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | 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 |
- orthostatic hypotension [ Time Frame: during study visit ]drop of systolic (≥20mmHg) or diastolic (≥10mmHg) blood pressure upon Schellong test
- delayed gastric emptying [ Time Frame: during study visit ]statistical difference in mean gastric emptying assessed via octanoate breath test
- long term blood pressure [ Time Frame: during 7d after study visit at home ]mean 7d systolic, diastolic, mean arterial blood pressure and heart rate recordings
- heart rate variability [ Time Frame: during study visit ]difference in heart rate variability or spectral analysis of heart rate variability?
- arterial stiffening [ Time Frame: during study visit ]difference in pulse wave velocity and augmentation index calculation from applanation tonometry recordings?
- oesophageal motility [ Time Frame: during study visit ]high-density manometry to measure aspects of oesophageal motility
- subjective symptoms of gastrointestinal and cardiovascular dysfunction [ Time Frame: during study visit ]validated questionnaires: Fraser, 2007, p14133; Stanghellini, 1996, p14183; Revicki, 2003, p13823; Kaufmann, 2012, p13817; }
- Clinical assessment [ Time Frame: during study visit ]UPDRS part III and MoCA score (Nasreddine, 2005, p14186)
| Enrollment: | 27 |
| Study Start Date: | December 2011 |
| Study Completion Date: | December 2014 |
| Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 50 Years to 70 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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)
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01518751
| Switzerland | |
| University Hospital Zurich, Neurology | |
| Zurich, ZH, Switzerland, 8091 | |
| Principal Investigator: | Christian Baumann, Ass. Prof., MD | University Hospital Zurich, Neurology |
More Information
Publications:
| Responsible Party: | University of Zurich |
| ClinicalTrials.gov Identifier: | NCT01518751 History of Changes |
| Other Study ID Numbers: |
KEK-ZH-NR. 2011-0077 |
| Study First Received: | January 17, 2012 |
| Last Updated: | September 29, 2015 |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |
ClinicalTrials.gov processed this record on September 21, 2017