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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002818
Receipt No. 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

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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
Email

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
Email kebihara@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Medicine and Clinical Science, Kyoto University Graduate School of Medicine
Translational Research Center, Kyoto University Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003433

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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