UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035557
Receipt number R000040487
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
Date of disclosure of the study information 2019/01/31
Last modified on 2020/04/03 09:14:43

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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 or person

Institute

Nippon Medical School Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040487


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name