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 |
Eligibility| Ages Eligible for Study: | 50 Years to 70 Years |
| Genders Eligible for Study: | Both |
| 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 Locations| Contact: Sebastian Schreglmann, MD | +41 (0)44 255 3393 | sebastian.schreglmann@usz.ch |
| Contact: Christian Baumann, Ass. Prof., MD | +41 (0)44 255 5502 | christian.baumann@usz.ch |
| Switzerland | |
| University Hospital Zurich, Neurology | Recruiting |
| Zurich, ZH, Switzerland, 8091 | |
| Principal Investigator: | Christian Baumann, Ass. Prof., MD | University Hospital Zurich, Neurology |
More Information
No publications provided
| 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: | January 27, 2012 |
| Health Authority: | Switzerland: Swissmedic |
Additional relevant MeSH terms:
|
Orthostatic Intolerance Autonomic Nervous System Diseases Primary Dysautonomias Parkinson Disease Nervous System Diseases Parkinsonian Disorders Basal Ganglia Diseases |
Brain Diseases Central Nervous System Diseases Movement Disorders Neurodegenerative Diseases Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013