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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01518751
First received: January 17, 2012
Last updated: November 18, 2013
Last verified: November 2013
History of Changes
  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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • orthostatic hypotension [ Time Frame: during study visit ] [ Designated as safety issue: No ]
    drop of systolic (≥20mmHg) or diastolic (≥10mmHg) blood pressure upon Schellong test


Secondary Outcome Measures:
  • delayed gastric emptying [ Time Frame: during study visit ] [ Designated as safety issue: No ]
    statistical difference in mean gastric emptying assessed via octanoate breath test

  • long term blood pressure [ Time Frame: during 7d after study visit at home ] [ Designated as safety issue: No ]
    mean 7d systolic, diastolic, mean arterial blood pressure and heart rate recordings

  • heart rate variability [ Time Frame: during study visit ] [ Designated as safety issue: No ]
    difference in heart rate variability or spectral analysis of heart rate variability?

  • arterial stiffening [ Time Frame: during study visit ] [ Designated as safety issue: No ]
    difference in pulse wave velocity and augmentation index calculation from applanation tonometry recordings?

  • oesophageal motility [ Time Frame: during study visit ] [ Designated as safety issue: No ]
    high-density manometry to measure aspects of oesophageal motility

  • subjective symptoms of gastrointestinal and cardiovascular dysfunction [ Time Frame: during study visit ] [ Designated as safety issue: No ]
    validated questionnaires: Fraser, 2007, p14133; Stanghellini, 1996, p14183; Revicki, 2003, p13823; Kaufmann, 2012, p13817; }

  • Clinical assessment [ Time Frame: during study visit ] [ Designated as safety issue: No ]
    UPDRS part III and MoCA score (Nasreddine, 2005, p14186)
Estimated Enrollment: 30
Study Start Date: December 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
  Eligibility
Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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)
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01518751

Contacts
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

Locations
Switzerland
University Hospital Zurich, Neurology Recruiting
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
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: November 18, 2013
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders

ClinicalTrials.gov processed this record on March 01, 2015