UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004665 |
|---|---|
| Receipt number | R000005555 |
| Scientific Title | The pathophysiological significance of abdominal fat on the status of GH secretion |
| Date of disclosure of the study information | 2010/12/03 |
| Last modified on | 2020/06/10 10:21:09 |
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Basic information
Public title
The pathophysiological significance of abdominal fat on the status of GH secretion
Acronym
The pathophysiological significance of abdominal fat on the status of GH secretion
Scientific Title
The pathophysiological significance of abdominal fat on the status of GH secretion
Scientific Title:Acronym
The pathophysiological significance of abdominal fat on the status of GH secretion
Region
| Japan |
Condition
Condition
Acromegaly, Adult GH deficiency
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the pathophysiological significance of abdominal fat on the status of GH secretion
Basic objectives2
Others
Basic objectives -Others
To investigate the pathophysiological significance of abdominal fat on the status of GH secretion
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the pathophysiological significance of abdominal fat on the status of GH secretion
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Duration 48 weeks
Acromegaly
surgery or drug therapy
Interventions/Control_2
Duration 48 weeks
Adult GH deficiency
GH replacement therapy
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Acromegaly
Patient whom surgery or drug therapy is indicated
Adult GH deficiency
patient whom GH replacement therapy is Indicated
Key exclusion criteria
Acromegaly
Patient who is unsuitable for this study (Judged by a
doctor)
Patient who has malignancy
Patient who is pregnant or may get pregnant
Adult GH deficiency
Patient who is unsuitable for this study (Judged by a
doctor)
Patient who has malignancy
Patient who is pregnant or may get pregnant
Patient who has diabetes mellitus
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michio Otsuki |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Metabolic Medicine
Zip code
Address
2-2 Yamada-oka, Suita, Osaka, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Metabolic Medicine
Zip code
Address
-2 Yamada-oka, Suita, Osaka, Japan
TEL
Homepage URL
Sponsor or person
Institute
Osaka University Graduate School of Medicine,
Department of Metabolic Medicine
Institute
Department
Personal name
Funding Source
Organization
Osaka University Graduate School of Medicine,
Department of Metabolic Medicine
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 | 12 | Month | 03 | 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
| 2009 | Year | 03 | Month | 09 | Day |
Date of IRB
| 2008 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2009 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 03 | Day |
Last modified on
| 2020 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005555
