UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025223 |
|---|---|
| Receipt number | R000029015 |
| Scientific Title | Growth Hormone (GH) Replacement Therapy Decreased Plasma Diacron-reactive Oxygen Metabolites levels and subsequently, improved Endothelial Function as Assessed by Peripheral Arterial Tonometry in Japanese Patient with growth Hormone deficiency |
| Date of disclosure of the study information | 2017/02/01 |
| Last modified on | 2017/10/16 21:54:38 |
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Basic information
Public title
Growth Hormone (GH) Replacement Therapy Decreased Plasma Diacron-reactive Oxygen Metabolites levels and subsequently, improved Endothelial Function as Assessed by Peripheral Arterial Tonometry in Japanese Patient with growth Hormone deficiency
Acronym
The effect of GH replacement therapy
Scientific Title
Growth Hormone (GH) Replacement Therapy Decreased Plasma Diacron-reactive Oxygen Metabolites levels and subsequently, improved Endothelial Function as Assessed by Peripheral Arterial Tonometry in Japanese Patient with growth Hormone deficiency
Scientific Title:Acronym
The effect of GH replacement therapy
Region
| Japan |
Condition
Condition
Growth Hormone Deficiency
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study was to elucidate the effect of growth hormone (GH) replacement therapy on diacron-reactive Oxygen Metabolites levels (d-ROMs) and endothelial function by peripheral arterial tonometry in Japanese patients with GH deficiency.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The changes in endothelial function and oxidative stress after GH replacement therapy
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
Patients with GH dificiency who unreceived GH replacement therapy were enrolled.
Endothelial function by reactive hyperaemia index(RHI; EndoPAT system), d-ROMS, blood pressure, fasting lipids. Plasma GH levels and insulin-like growth factor -1 were also measured at baseline and following GH replacement after 24 weeks.
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
| Not applicable |
Age-upper limit
| 16 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
GH deficient hypopituitary subjects
Key exclusion criteria
1.type 1 or 2 diabetes,
2.severe liver dysfunction
3.severe infections
4.pregnant or nursing women and those who might be pregnant
5.malignancy or the history of malignancy
6.alcoholism
7 any patients whom the investigators judged to be inappropriate for this study.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshimasa Aso |
Organization
Dokkyo Medical University
Division name
Endocrinology and Metabolism
Zip code
Address
880 Kita-Kobayashi, Mibu, Shimotsuga, Tochigi, Japan
TEL
0282-86-1111
yaso@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chie Aoki |
Organization
Dokkyo Medical University
Division name
Endocrinology and Metabolism
Zip code
Address
880 Kita-Kobayashi, Mibu, Shimotsuga, Tochigi, Japan
TEL
0282-86-1111
Homepage URL
c-aoki@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Dokkyo Medical University
Organization
Division
Category of Funding Organization
Self funding
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
| 2017 | Year | 02 | 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
| 2016 | Year | 12 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 04 | 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
| 2016 | Year | 12 | Month | 12 | Day |
Last modified on
| 2017 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029015
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
