UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017036 |
|---|---|
| Receipt number | 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 12:46:36 |
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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
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
itohm@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017618
