UMIN-CTR Clinical Trial

Basic information
Public title	Study on clinical characteristics and response of growth hormone(GH) during GH releasing peptide (GHRP)-2 test in patients with non-functioning pituitary adenomas
Acronym	Study on clinical characteristics and response of growth hormone(GH) during GH releasing peptide (GHRP)-2 test in patients with non-functioning pituitary adenomas
Scientific Title	Study on clinical characteristics and response of growth hormone(GH) during GH releasing peptide (GHRP)-2 test in patients with non-functioning pituitary adenomas
Scientific Title:Acronym	Study on clinical characteristics and response of growth hormone(GH) during GH releasing peptide (GHRP)-2 test in patients with non-functioning pituitary adenomas
Region	Japan

Condition
Condition	Adult growth hormone deficiency (AGHD)
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In Japan, the GH releasing peptide (GHRP)-2 test is used to evaluate GH secretion. Although the cut-off levels of peak GH during GHRP-2 test for severe AGHD is 9 ng/ml, those values in patients with severe AGHD may vary from no-response to up to 9 ng/ml. We studied whether peak GH response during GHRP-2 test had an effect on difference in clinical characteristics in patients with NFPA.
Basic objectives2	Others
Basic objectives -Others	The patients with severe AGHD were divided into two groups depending on median of the preoperative GH peak values during the GHRP-2 test.We examined factors related to differences in two groups.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Clarification of the difference between clinical characteristics and response of growth hormone(GH) during GH releasing peptide (GHRP)-2 test in patients with non-functioning pituitary adenomas.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Gender	Male and Female
Key inclusion criteria	76 patients who were underwent transsphenoidal surgery at Nippon Medical School Hospital between October 2012 and November 2017.
Key exclusion criteria	Patients who had a history of previous transsphenoidal surgery were excluded from the study.
Target sample size	76

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hitoshi Sugihara
Organization	Nippon Medical School Hospital
Division name	Department of Endocrinology, Diabetes and Metabolism
Zip code
Address	1-1-5,Sendagi,Bunkyo-ku,Tokyo,113-8603,Japan
TEL	03-3822-2131
Email	hitoshi@nms.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Izumi Fukuda
Organization	Nippon Medical School Hospital
Division name	Department of Endocrinology, Diabetes and Metabolism
Zip code
Address	1-1-5,Sendagi,Bunkyo-ku,Tokyo,113-8603,Japan
TEL	03-3822-2131
Homepage URL
Email	i-fukuda@nms.ac.jp

Sponsor
Institute	Nippon Medical School Hospital
Institute
Department

Funding Source
Organization	Nippon Medical School 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	2019 Year 01 Month 31 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 04 Month 01 Day
Date of IRB	2019 Year 01 Month 07 Day
Anticipated trial start date	2019 Year 09 Month 10 Day
Last follow-up date	2019 Year 09 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Retrospective study

Management information
Registered date	2019 Year 01 Month 16 Day
Last modified on	2020 Year 04 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040487