UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002818 |
|---|---|
| Receipt number | R000003433 |
| Scientific Title | Phase 2 trial of leptin-replacement therapy for patients with lipodystrophy |
| Date of disclosure of the study information | 2010/01/01 |
| Last modified on | 2012/06/07 13:15:20 |
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Basic information
Public title
Phase 2 trial of leptin-replacement therapy for patients with lipodystrophy
Acronym
Leptin-replacement therapy on lipodystrophy
Scientific Title
Phase 2 trial of leptin-replacement therapy for patients with lipodystrophy
Scientific Title:Acronym
Leptin-replacement therapy on lipodystrophy
Region
| Japan |
Condition
Condition
lipodystrophy
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To verify the efficacy on diabetes, hyperinsulinemia and hypertriglyceridemia and safety of leptin-replacement therapy in patients with lipodystrophy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c level, fasting serum insulin level, fasting serum triglyceride level and adverse event
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
administration of recombinant methionyl human 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 lipodystrophy
2. hypoleptinemia
3. diagnosis of diabetes or hyperinsulinemia
Key exclusion criteria
1. alcohol or drug dependence
2. in use of anorectic agents
3. in pregnancy, while breast-feeding
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuwa Nakaoa |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Medicine and Clinical Science
Zip code
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken Ebihara |
Organization
Kyoto University Hospital
Division name
Translational Research Center
Zip code
Address
TEL
Homepage URL
kebihara@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Medicine and Clinical Science, Kyoto University Graduate School of Medicine
Translational Research Center, Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
subsidy of administrative cost
Organization
Division
Category of Funding Organization
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 | 01 | 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 | 04 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 09 | 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 | 12 | Month | 01 | Day |
Last modified on
| 2012 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003433
