UMIN-CTR Clinical Trial

Basic information
Public title	Prospective Observational Study on the Effects of Long-Acting Human Growth Hormone Analogues on Quality of Life and Quality of Sleep
Acronym	Prospective Observational Study on the Effects of Long-Acting Human Growth Hormone Analogues on Quality of Life and Quality of Sleep
Scientific Title	Prospective Observational Study on the Effects of Long-Acting Human Growth Hormone Analogues on Quality of Life and Quality of Sleep
Scientific Title:Acronym	Prospective Observational Study on the Effects of Long-Acting Human Growth Hormone Analogues on Quality of Life and Quality of Sleep
Region	Japan

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

Objectives
Narrative objectives1	The purpose of this study was to investigate the effect of a long-acting human growth hormone analogue, Somapacitan, on quality of life and quality of sleep in patients with adult growth hormone deficiency (AGHD).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in Athens Insomnia Scale score before and after starting or changing Somapacitan
Key secondary outcomes	1) Change in SF-36 score before and after starting or changing Somapacitan 2) Change in blood examination before and after starting or changing Somapacitan 3) Change in body composition before and after starting or changing Somapacitan 4) Adverse events during the observation period

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Patients with AGHD requiring Somapacitan therapy (2) Patients who are 20 years of age or older at the time of obtaining consent (3) Patients who have been fully informed about their participation in this study, and who have given written consent of their own free will based on their full understanding of the study.
Key exclusion criteria	(1) Patients with contraindications to Somapacitan (2) Other subjects deemed inappropriate as research subjects by the investigator
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Hideki Middle name Last name Yamaguchi
Organization	Department of Internal Medicine, Faculty of Internal Medicine, University of Miyazaki
Division name	Division of Hematology, Diabetes, and Endocrinology
Zip code	8891692
Address	5200 Kihara Kiyotake, Miyazaki 889-1692 Japan.
TEL	0985859121
Email	hideki_yamaguchi@med.miyazaki-u.ac.jp

Public contact
Name of contact person	1st name Taisuke Middle name Last name Uchida
Organization	Department of Internal Medicine, Faculty of Internal Medicine, University of Miyazaki
Division name	Division of Hematology, Diabetes, and Endocrinology
Zip code	8891692
Address	5200 Kihara Kiyotake, Miyazaki 889-1692 Japan.
TEL	0985859121
Homepage URL
Email	taisuke_uchida@med.miyazaki-u.ac.jp

Sponsor
Institute	Faculty of Internal Medicine, University of Miyazaki
Institute
Department

Funding Source
Organization	Self funding
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	University of Miyazaki Hospital, Clinical Research Support Center
Address	5200 Kihara Kiyotake, Miyazaki 889-1692 Japan.
Tel	0985859121
Email	rinken@med.miyazaki-u.ac.jp

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	2024 Year 12 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	Preinitiation
Date of protocol fixation	2022 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date	2022 Year 09 Month 01 Day
Last follow-up date	2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Obtaining consent Research subjects will be selected based on the selection and exclusion criteria. The investigator will obtain written consent. Baseline Examination Baseline laboratory tests will be the values prior to the start of Somapacitan. In addition to blood tests, body composition (using InBody720), quality of life questionnaire (using SF-36), and sleep questionnaire (using AIS) will be administered to study subjects at baseline. Observation point 4 weeks Four weeks after the observation start date, an observation point will be established. Quality of life questionnaires, sleep assessment questionnaires, and body composition test will be administered in addition to blood tests. Observation point 8 weeks Eight weeks after the observation start date, an observation point will be established. Sleep assessment questionnaires and body composition test will be administered in addition to blood tests. Observation point 12 weeks Twelve weeks after the observation start date, an observation point will be established. Quality of life questionnaires, sleep assessment questionnaires, and body composition test will be administered in addition to blood tests. The allowable range for the 12-week observation point is 12 to 24 weeks.

Management information
Registered date	2022 Year 08 Month 04 Day
Last modified on	2022 Year 08 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055357