{
  "FullStudy":{
    "Rank":217641,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01518751",
          "OrgStudyIdInfo":{
            "OrgStudyId":"KEK-ZH-NR. 2011-0077"
          },
          "Organization":{
            "OrgFullName":"University of Zurich",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Orthostatic Dysregulation and Associated Gastrointestinal Dysfunction in Parkinson's Disease - Evolution",
          "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"
        },
        "StatusModule":{
          "StatusVerifiedDate":"September 2015",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"December 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"December 2013",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"December 2014",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 17, 2012",
          "StudyFirstSubmitQCDate":"January 23, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 26, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"September 29, 2015",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"September 30, 2015",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"University of Zurich",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "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."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Parkinson`s Disease - Autonomic Dysregulation"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Case Control"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Prospective"
              ]
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"27",
            "EnrollmentType":"Actual"
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"orthostatic hypotension",
                "PrimaryOutcomeDescription":"drop of systolic (≥20mmHg) or diastolic (≥10mmHg) blood pressure upon Schellong test",
                "PrimaryOutcomeTimeFrame":"during study visit"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"delayed gastric emptying",
                "SecondaryOutcomeDescription":"statistical difference in mean gastric emptying assessed via octanoate breath test",
                "SecondaryOutcomeTimeFrame":"during study visit"
              },{
                "SecondaryOutcomeMeasure":"long term blood pressure",
                "SecondaryOutcomeDescription":"mean 7d systolic, diastolic, mean arterial blood pressure and heart rate recordings",
                "SecondaryOutcomeTimeFrame":"during 7d after study visit at home"
              },{
                "SecondaryOutcomeMeasure":"heart rate variability",
                "SecondaryOutcomeDescription":"difference in heart rate variability or spectral analysis of heart rate variability?",
                "SecondaryOutcomeTimeFrame":"during study visit"
              },{
                "SecondaryOutcomeMeasure":"arterial stiffening",
                "SecondaryOutcomeDescription":"difference in pulse wave velocity and augmentation index calculation from applanation tonometry recordings?",
                "SecondaryOutcomeTimeFrame":"during study visit"
              },{
                "SecondaryOutcomeMeasure":"oesophageal motility",
                "SecondaryOutcomeDescription":"high-density manometry to measure aspects of oesophageal motility",
                "SecondaryOutcomeTimeFrame":"during study visit"
              },{
                "SecondaryOutcomeMeasure":"subjective symptoms of gastrointestinal and cardiovascular dysfunction",
                "SecondaryOutcomeDescription":"validated questionnaires: Fraser, 2007, p14133; Stanghellini, 1996, p14183; Revicki, 2003, p13823; Kaufmann, 2012, p13817; }",
                "SecondaryOutcomeTimeFrame":"during study visit"
              },{
                "SecondaryOutcomeMeasure":"Clinical assessment",
                "SecondaryOutcomeDescription":"UPDRS part III and MoCA score (Nasreddine, 2005, p14186)",
                "SecondaryOutcomeTimeFrame":"during study visit"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion criteria: - informed, written & formal consent for participation\n\nmale/female subjects, aged 50-70 years\nPD patients (9 subjects each in Hoehn & Yahr stage 1 & 2)\n\nExclusion criteria: - Antihypertensive treatment\n\nmedication influencing gastrointestinal motility for at least the elimination half life of the drug\nmedication interfering with blood-pressure regulation for at least the elimination half life of the drug\nsignificant systemic illness\nBMI < 18 or > 30kg/m2\nsymptoms or a history of GI disease or surgery\nwith any evidence of infectious disease\nevidence or history of drug or alcohol abuse\ndiabetes mellitus",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"50 Years",
          "MaximumAge":"70 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          },
          "StudyPopulation":"Subjects included in this trial must fulfil the he following criteria:\n\ninformed, written & formal consent for participation\n\nmale / female subjects, aged 50-70 years\n\n18 PD patients\n\n9 subjects Hoehn & Yahr stage 1, disease duration <4 years\n\n9 subjects Hoehn & Yahr stage 2; disease duration 4-8 years\n\n12 healthy control subjects\n\nage- and gender-matched\nwithout signs or history of neurological disorders\nwithout significant systemic comorbidities (malignant / cardiovascular)",
          "SamplingMethod":"Non-Probability Sample"
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Christian Baumann, Ass. Prof., MD",
                "OverallOfficialAffiliation":"University Hospital Zurich, Neurology",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"University Hospital Zurich, Neurology",
                "LocationCity":"Zurich",
                "LocationState":"ZH",
                "LocationZip":"8091",
                "LocationCountry":"Switzerland"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"26048686",
                "ReferenceType":"result",
                "ReferenceCitation":"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."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000010300",
                "ConditionMeshTerm":"Parkinson Disease"
              },{
                "ConditionMeshId":"D000001342",
                "ConditionMeshTerm":"Autonomic Nervous System Diseases"
              },{
                "ConditionMeshId":"D000054969",
                "ConditionMeshTerm":"Primary Dysautonomias"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000020734",
                "ConditionAncestorTerm":"Parkinsonian Disorders"
              },{
                "ConditionAncestorId":"D000001480",
                "ConditionAncestorTerm":"Basal Ganglia Diseases"
              },{
                "ConditionAncestorId":"D000001927",
                "ConditionAncestorTerm":"Brain Diseases"
              },{
                "ConditionAncestorId":"D000002493",
                "ConditionAncestorTerm":"Central Nervous System Diseases"
              },{
                "ConditionAncestorId":"D000009422",
                "ConditionAncestorTerm":"Nervous System Diseases"
              },{
                "ConditionAncestorId":"D000009069",
                "ConditionAncestorTerm":"Movement Disorders"
              },{
                "ConditionAncestorId":"D000019636",
                "ConditionAncestorTerm":"Neurodegenerative Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M11796",
                "ConditionBrowseLeafName":"Parkinson Disease",
                "ConditionBrowseLeafAsFound":"Parkinson's Disease",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M26566",
                "ConditionBrowseLeafName":"Primary Dysautonomias",
                "ConditionBrowseLeafAsFound":"Autonomic Dysregulation",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M3224",
                "ConditionBrowseLeafName":"Autonomic Nervous System Diseases",
                "ConditionBrowseLeafAsFound":"Autonomic Dysregulation",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M21078",
                "ConditionBrowseLeafName":"Parkinsonian Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M24190",
                "ConditionBrowseLeafName":"Ganglion Cysts",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M14941",
                "ConditionBrowseLeafName":"Synovial Cyst",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3355",
                "ConditionBrowseLeafName":"Basal Ganglia Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3786",
                "ConditionBrowseLeafName":"Brain Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M4325",
                "ConditionBrowseLeafName":"Central Nervous System Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10612",
                "ConditionBrowseLeafName":"Movement Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M20142",
                "ConditionBrowseLeafName":"Neurodegenerative Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC10",
                "ConditionBrowseBranchName":"Nervous System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC04",
                "ConditionBrowseBranchName":"Cancers and Other Neoplasms"
              },{
                "ConditionBrowseBranchAbbrev":"BC17",
                "ConditionBrowseBranchName":"Skin and Connective Tissue Diseases"
              }
            ]
          }
        }
      }
    }
  }
}