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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01518751
Enrollment
27
Registered
2012-01-26
Start date
2011-12-31
Completion date
2014-12-31
Last updated
2015-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease - Autonomic Dysregulation

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.

Interventions

None listed

Sponsors

University of Zurich
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
orthostatic hypotensionduring study visitdrop of systolic (≥20mmHg) or diastolic (≥10mmHg) blood pressure upon Schellong test

Secondary

MeasureTime frameDescription
long term blood pressureduring 7d after study visit at homemean 7d systolic, diastolic, mean arterial blood pressure and heart rate recordings
heart rate variabilityduring study visitdifference in heart rate variability or spectral analysis of heart rate variability?
arterial stiffeningduring study visitdifference in pulse wave velocity and augmentation index calculation from applanation tonometry recordings?
delayed gastric emptyingduring study visitstatistical difference in mean gastric emptying assessed via octanoate breath test
subjective symptoms of gastrointestinal and cardiovascular dysfunctionduring study visitvalidated questionnaires: Fraser, 2007, p14133; Stanghellini, 1996, p14183; Revicki, 2003, p13823; Kaufmann, 2012, p13817; }
Clinical assessmentduring study visitUPDRS part III and MoCA score (Nasreddine, 2005, p14186)
oesophageal motilityduring study visithigh-density manometry to measure aspects of oesophageal motility

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026