Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-02-24 @ 3:53 AM
Study NCT ID:
NCT01518751
Status:
COMPLETED
Last Update Posted:
2015-09-30
First Post:
2012-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Orthostatic Dysregulation and Associated Gastrointestinal Dysfunction in Parkinson's Disease - Evolution
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-29', 'studyFirstSubmitDate': '2012-01-17', 'studyFirstSubmitQcDate': '2012-01-23', 'lastUpdatePostDateStruct': {'date': '2015-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'orthostatic hypotension', 'timeFrame': 'during study visit', 'description': 'drop of systolic (≥20mmHg) or diastolic (≥10mmHg) blood pressure upon Schellong test'}], 'secondaryOutcomes': [{'measure': 'delayed gastric emptying', 'timeFrame': 'during study visit', 'description': 'statistical difference in mean gastric emptying assessed via octanoate breath test'}, {'measure': 'long term blood pressure', 'timeFrame': 'during 7d after study visit at home', 'description': 'mean 7d systolic, diastolic, mean arterial blood pressure and heart rate recordings'}, {'measure': 'heart rate variability', 'timeFrame': 'during study visit', 'description': 'difference in heart rate variability or spectral analysis of heart rate variability?'}, {'measure': 'arterial stiffening', 'timeFrame': 'during study visit', 'description': 'difference in pulse wave velocity and augmentation index calculation from applanation tonometry recordings?'}, {'measure': 'oesophageal motility', 'timeFrame': 'during study visit', 'description': 'high-density manometry to measure aspects of oesophageal motility'}, {'measure': 'subjective symptoms of gastrointestinal and cardiovascular dysfunction', 'timeFrame': 'during study visit', 'description': 'validated questionnaires: Fraser, 2007, p14133; Stanghellini, 1996, p14183; Revicki, 2003, p13823; Kaufmann, 2012, p13817; }'}, {'measure': 'Clinical assessment', 'timeFrame': 'during study visit', 'description': 'UPDRS part III and MoCA score (Nasreddine, 2005, p14186)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ["Parkinson's Disease - Autonomic Dysregulation"]}, 'referencesModule': {'references': [{'pmid': '26048686', 'type': 'RESULT', 'citation': "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. Epub 2015 Jun 6."}]}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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.\n\nThe 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects included in this trial must fulfil the he following criteria:\n\n* informed, written \\& formal consent for participation\n* male / female subjects, aged 50-70 years\n\n 18 PD patients\n* 9 subjects Hoehn \\& Yahr stage 1, disease duration \\<4 years\n* 9 subjects Hoehn \\& Yahr stage 2; disease duration 4-8 years\n\n 12 healthy control subjects\n* age- and gender-matched\n* without signs or history of neurological disorders\n* without significant systemic comorbidities (malignant / cardiovascular)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria: - informed, written \\& formal consent for participation\n\n* male/female subjects, aged 50-70 years\n* PD patients (9 subjects each in Hoehn \\& Yahr stage 1 \\& 2)\n\nExclusion criteria: - Antihypertensive treatment\n\n* medication influencing gastrointestinal motility for at least the elimination half life of the drug\n* medication interfering with blood-pressure regulation for at least the elimination half life of the drug\n* significant systemic illness\n* BMI \\< 18 or \\> 30kg/m2\n* symptoms or a history of GI disease or surgery\n* with any evidence of infectious disease\n* evidence or history of drug or alcohol abuse\n* diabetes mellitus'}, 'identificationModule': {'nctId': 'NCT01518751', 'briefTitle': "Orthostatic Dysregulation and Associated Gastrointestinal Dysfunction in Parkinson's Disease - Evolution", 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': "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", 'orgStudyIdInfo': {'id': 'KEK-ZH-NR. 2011-0077'}}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zurich, Neurology', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Christian Baumann, Ass. Prof., MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Zurich, Neurology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}