Parkinson's Disease - Autonomic DysregulationNCT01518751
Orthostatic Dysregulation and Associated Gastrointestinal Dysfunction in Parkinson's Disease - Evolution
An observational study of Parkinson's Disease - Autonomic Dysregulation, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease - Autonomic Dysregulation
- How many people
- 27 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2011to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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)
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Neurology
Zurich, Canton of Zurich, 8091
About this study
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
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.
Read more
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
orthostatic hypotension
drop of systolic (≥20mmHg) or diastolic (≥10mmHg) blood pressure upon Schellong test
Measured: during study visit
Secondary outcomes (7)
delayed gastric emptying
statistical difference in mean gastric emptying assessed via octanoate breath test
Measured: during study visit
long term blood pressure
mean 7d systolic, diastolic, mean arterial blood pressure and heart rate recordings
Measured: during 7d after study visit at home
heart rate variability
difference in heart rate variability or spectral analysis of heart rate variability?
Measured: during study visit
arterial stiffening
difference in pulse wave velocity and augmentation index calculation from applanation tonometry recordings?
Measured: during study visit
oesophageal motility
high-density manometry to measure aspects of oesophageal motility
Measured: during study visit
subjective symptoms of gastrointestinal and cardiovascular dysfunction
validated questionnaires: Fraser, 2007, p14133; Stanghellini, 1996, p14183; Revicki, 2003, p13823; Kaufmann, 2012, p13817; }
Measured: during study visit
Clinical assessment
UPDRS part III and MoCA score (Nasreddine, 2005, p14186)
Measured: during study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2012 (estimated)
- Study startDec 2011
- Primary completionDec 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's Disease - Autonomic DysregulationStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Baumann, Ass. Prof., MD, Principal investigator, University Hospital Zurich, Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01518751
- Sponsor's protocol ID
- KEK-ZH-NR. 2011-0077
- Status last verified
- Sep 2015
- First submitted
- 17 Jan 2012
- Last updated
- 30 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26048686
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01518751
- Acronym / sponsor ID
- KEK-ZH-NR. 2011-0077
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 26 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
orthostatic hypotension
Time frame: during study visit
drop of systolic (≥20mmHg) or diastolic (≥10mmHg) blood pressure upon Schellong test
7 secondary outcomes
delayed gastric emptying
Time frame: during study visit
long term blood pressure
Time frame: during 7d after study visit at home
heart rate variability
Time frame: during study visit
arterial stiffening
Time frame: during study visit
oesophageal motility
Time frame: during study visit
subjective symptoms of gastrointestinal and cardiovascular dysfunction
Time frame: during study visit
Clinical assessment
Time frame: during study visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2015.
- Results publication: PubMed 26048686Epprecht 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Baumann, Ass. Prof., MD principal investigator
University Hospital Zurich, Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease - Autonomic Dysregulation, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
orthostatic hypotension (time frame: during study visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01518751, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2015.