UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Association of ghrelin and leptin in cardiovascular autonomic dysfunction in patients with primary dysautonomia.
Title of the study (Brief title)	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.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Sobue Gen
Organization	Nagoya University Graduate School of Medicine
Division name	neurology
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	Ito Mizuki
Organization	Nagoya University Graduate School of Medicine
Division name	neurology
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 04 Month 03 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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-bin/icdr_e/ctr_view.cgi?recptno=R000017618