UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Yoshimasa Aso
Organization	Dokkyo Medical University
Division name	Endocrinology and Metabolism
Address	880 Kita-Kobayashi, Mibu, Shimotsuga, Tochigi, Japan
TEL	0282-86-1111
Email	yaso@dokkyomed.ac.jp

Public contact
Name of contact person	Chie Aoki
Organization	Dokkyo Medical University
Division name	Endocrinology and Metabolism
Address	880 Kita-Kobayashi, Mibu, Shimotsuga, Tochigi, Japan
TEL	0282-86-1111
Homepage URL
Email	c-aoki@dokkyomed.ac.jp

Sponsor
Institute	Dokkyo Medical University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029015