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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001707
Receipt No. 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

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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
Email

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
Email intron@med.miyazaki-u.ac.jp

Sponsor
Institute Neurology, Respirology, Endocrinology and Metabolism,
Miyazaki Medical College, University of Miyazaki
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001820

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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