UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001707 |
|---|---|
| Receipt number | R000001820 |
| Scientific Title | Clinical study of ghrelin administration on diabetic neuropathy |
| Date of disclosure of the study information | 2009/02/16 |
| Last modified on | 2015/02/13 17:04:59 |
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Basic information
Public title
Clinical study of ghrelin administration on diabetic neuropathy
Acronym
Clinical study of ghrelin on diabetic neuropathy
Scientific Title
Clinical study of ghrelin administration on diabetic neuropathy
Scientific Title:Acronym
Clinical study of ghrelin on diabetic neuropathy
Region
| Japan |
Condition
Condition
type2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of efficacy and safety of ghrelin administration to diabetic neuropathy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Improvement of diabetic neuropathy. Changes of glucose metabolism and appetite.
Key secondary outcomes
Insulin secretion capacity.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
two weeks ghrelin administration
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Type2 diabetes with diabetic neuropathy.
HbA1c<9.1%
Key exclusion criteria
Insulin treatment.
Severe liver or renal dysfunction.
Severe heart diseases.
Proliferative diabetic retinopathy.
Medication with epalrestat, anti-eplepsy drugs, or mexiletine.
Pregnant women.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masamitsu Nakazato |
Organization
Miyazaki Medical College, University of Miyazaki
Division name
Neurology, Respirology, Endocrinology and Metabolism
Zip code
Address
5200, kihara, Kiyotake, Miyazaki, Japan
TEL
0985-85-9246
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroaki Ueno |
Organization
Miyazaki Medical College, University of Miyazaki
Division name
Neurology, Respirology, Endocrinology and Metabolism
Zip code
Address
5200, kihara, Kiyotake, Miyazaki, Japan
TEL
0985-85-9246
Homepage URL
intron@med.miyazaki-u.ac.jp
Sponsor or person
Institute
Neurology, Respirology, Endocrinology and Metabolism,
Miyazaki Medical College, University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
Ministry of education, culture, sports, science & technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2009 | Year | 02 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2008 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 02 | Month | 13 | Day |
Last modified on
| 2015 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001820
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
