Skip to main content
OpenTrials
Completed

NCT Number: NCT01518751

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Zurich, Neurology

Zurich, Canton of Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. orthostatic hypotension

    Time frame: during study visit

    drop of systolic (≥20mmHg) or diastolic (≥10mmHg) blood pressure upon Schellong test

Secondary outcomes

  1. delayed gastric emptying

    Time frame: during study visit

    statistical difference in mean gastric emptying assessed via octanoate breath test

  2. 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

  3. heart rate variability

    Time frame: during study visit

    difference in heart rate variability or spectral analysis of heart rate variability?

  4. arterial stiffening

    Time frame: during study visit

    difference in pulse wave velocity and augmentation index calculation from applanation tonometry recordings?

  5. oesophageal motility

    Time frame: during study visit

    high-density manometry to measure aspects of oesophageal motility

  6. 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; }

  7. Clinical assessment

    Time frame: during study visit

    UPDRS part III and MoCA score (Nasreddine, 2005, p14186)

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Jan 26, 2012
Registry last updated
Sep 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.