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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017036
Receipt No. R000017618
Scientific Title Association of ghrelin and leptin in cardiovascular autonomic dysfunction in patients with primary dysautonomia.
Date of disclosure of the study information 2015/04/03
Last modified on 2016/04/04

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Basic information
Public title Association of ghrelin and leptin in cardiovascular autonomic dysfunction in patients with primary dysautonomia.
Acronym Association of ghrelin and leptin in cardiovascular autonomic dysfunction
Scientific Title Association of ghrelin and leptin in cardiovascular autonomic dysfunction in patients with primary dysautonomia.
Scientific Title:Acronym Association of ghrelin and leptin in cardiovascular autonomic dysfunction
Region
Japan

Condition
Condition autonomic failure such as Parkinson's disease
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the role of ghrelin and leptin in cardiovascular autonomic dysfunction in patients with primary dysautonomia. These two hormones are reported to have some effect to cardiovascular hemodynamics. But there were no studies focusing on patients with primary dysautonomia.
Basic objectives2 Others
Basic objectives -Others If these hormones have some relation with cardiovascular dysautonomia, this may lead to the improvement of quality of life in dysautonomic patients.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes We evaluate the relation with these hormones and cardiac parameters such as orthstatic hypotention, postprandial hypotension, CVR-R, and cardiac MIBG. The first two years, we collect the date of about 50 patients and 25 normal controls. If there exist any relation with the secretion and cardiovascular dysautonomia, we will follow the patients and observe whether the progression of the disease have some relation with these hormons.
Key secondary outcomes We also evaluate the relation with drug, smell function, MMSE, and UPDRS.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 blood test of Leptin and Ghrelin
Interventions/Control_2 blood test of Leptin and Ghrelin
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria neurodegenerating disease with autonomic dysfunction
Key exclusion criteria Individuals with diabetes mellitus, any known heart disease, hypertension, Cussing syndrome, rheumatism, difficulty in blood drawing, or other neurological disorders were excluded.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sobue Gen
Organization Nagoya University Graduate School of Medicine
Division name neurology
Zip code
Address 65 Tsurumai-cho Showa-ku Nagoya
TEL +81-52-744-2385
Email sobueg@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ito Mizuki
Organization Nagoya University Graduate School of Medicine
Division name neurology
Zip code
Address 65 Tsurumai-cho Showa-ku Nagoya
TEL +81-52-744-2385
Homepage URL
Email itohm@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 03 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 04 Month 03 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 03 Day
Last follow-up date
2016 Year 02 Month 29 Day
Date of closure to data entry
2016 Year 03 Month 31 Day
Date trial data considered complete
2016 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 04 Month 03 Day
Last modified on
2016 Year 04 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017618

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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