Parkinson`s Disease - Autonomic Dysregulation Clinical Trial
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
| Verified date | September 2015 |
| Source | University of Zurich |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Switzerland: Swissmedic |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 27 |
| Est. completion date | December 2014 |
| Est. primary completion date | December 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 50 Years to 70 Years |
| Eligibility |
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 |
Observational Model: Case Control, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | University Hospital Zurich, Neurology | Zurich | ZH |
| Lead Sponsor | Collaborator |
|---|---|
| University of Zurich |
Switzerland,
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. E — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | orthostatic hypotension | drop of systolic (=20mmHg) or diastolic (=10mmHg) blood pressure upon Schellong test | during study visit | No |
| Secondary | delayed gastric emptying | statistical difference in mean gastric emptying assessed via octanoate breath test | during study visit | No |
| Secondary | long term blood pressure | mean 7d systolic, diastolic, mean arterial blood pressure and heart rate recordings | during 7d after study visit at home | No |
| Secondary | heart rate variability | difference in heart rate variability or spectral analysis of heart rate variability? | during study visit | No |
| Secondary | arterial stiffening | difference in pulse wave velocity and augmentation index calculation from applanation tonometry recordings? | during study visit | No |
| Secondary | oesophageal motility | high-density manometry to measure aspects of oesophageal motility | during study visit | No |
| Secondary | subjective symptoms of gastrointestinal and cardiovascular dysfunction | validated questionnaires: Fraser, 2007, p14133; Stanghellini, 1996, p14183; Revicki, 2003, p13823; Kaufmann, 2012, p13817; } | during study visit | No |
| Secondary | Clinical assessment | UPDRS part III and MoCA score (Nasreddine, 2005, p14186) | during study visit | No |