UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003679 |
|---|---|
| Receipt number | R000003470 |
| Scientific Title | Long-term safety clinical trial of leptin-replacement therapy in patients with lipodystrophy after introduction of the treatment |
| Date of disclosure of the study information | 2010/06/01 |
| Last modified on | 2015/06/01 09:51:40 |
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Basic information
Public title
Long-term safety clinical trial of leptin-replacement therapy in patients with lipodystrophy after introduction of the treatment
Acronym
Long-term safety clinical trial of leptin in lipodystrophy
Scientific Title
Long-term safety clinical trial of leptin-replacement therapy in patients with lipodystrophy after introduction of the treatment
Scientific Title:Acronym
Long-term safety clinical trial of leptin in lipodystrophy
Region
| Japan |
Condition
Condition
lipodytrophy
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the long-term safety and efficacy on glucose and lipid metabolism of leptin replacement therapy in patients after introduction of the therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
adverse event, HbA1c, fasting glucose level, fasting triglyceride level, fasting insulin level
Key secondary outcomes
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
subcutaneous injection of human recombinant leptin
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
| 6 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Diagnosis of lipodusytophy
2. Treated with leptin-replacement therapy over 2 months safely and improved in metabolic abnormalities after initiation of the therapy
Key exclusion criteria
1. Existence of complications or history which become problem for long-term leptin-replacement therapy
2. In pregnancy or nursing
Target sample size
11
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken Ebihara |
Organization
Translational Research Center
Kyoto University Hospital
Division name
Department od Experimental Therapeutics
Zip code
Address
54 Shogoin, Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL
075-751-3173
kebihara@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken Ebihara |
Organization
Translational Research Center, Kyoto University Hospital
Division name
Department od Experimental Therapeutics
Zip code
Address
54 Shogoin, Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL
075-751-3173
Homepage URL
kebihara@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kyoto University Hospital
Organization
Division
Category of Funding Organization
Other
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
| 2010 | Year | 06 | Month | 01 | 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
| 2010 | Year | 03 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 31 | Day |
Last modified on
| 2015 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003470
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| Registered date | File name |
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| Registered date | File name |
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