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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003679
Receipt No. 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

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

Sponsor
Institute Kyoto University Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003470

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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