UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049954 |
|---|---|
| Receipt number | R000056894 |
| Scientific Title | Clinical investigation of the changes in endocrinological and metabolic parameters on patients with adult growth hormone deficiency between daily and weekly growth hormone replacement therapy. |
| Date of disclosure of the study information | 2023/01/04 |
| Last modified on | 2025/01/03 14:33:25 |
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Basic information
Public title
Clinical investigation of the changes in endocrinological and metabolic parameters on patients with adult growth hormone deficiency between daily and weekly growth hormone replacement therapy.
Acronym
Investigation of the changes in patients with adult growth hormone deficiency between daily and weekly growth hormone replacement therapy.
Scientific Title
Clinical investigation of the changes in endocrinological and metabolic parameters on patients with adult growth hormone deficiency between daily and weekly growth hormone replacement therapy.
Scientific Title:Acronym
Investigation of the changes in patients with adult growth hormone deficiency between daily and weekly growth hormone replacement therapy.
Region
| Japan |
Condition
Condition
Adult growth hormone deficiency
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Recently, patients with growth hormone (GH) deficiency (aGHD) could be treated by weekly GH replacement therapy (long-acting GH: somapcitan). The efficacy and safety of somapcitan were revealed in some clinical trials, while real-world data has not been reported. Thus, we aim to investigate them in patients with aGHD whose treatment changed from daily GH treatment therapy to weekly GH treatment therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in body mass index
Key secondary outcomes
Changes in metabolic and endocrinological parameters
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals with aGHD who had received daily GH replacement therapy and switched from daily GH replacement therapy to weekly GH replacement therapy between January 2022 and June 2022.
Key exclusion criteria
Individuals with aGHD who had not received daily GH replacement therapy, individuals whose treatments except GH replacement therapy have changed in the period, and individuals whose IGF1 changed over 1SD.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Kunihisa |
| Middle name | |
| Last name | Kobayashi |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of endocrinology and diabetes mellitus
Zip code
8188502
Address
1-1-1 Zokumyoin, Chikushino
TEL
+81929211011
nihisak@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Kunihisa |
| Middle name | |
| Last name | Kobayashi |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of endocrinology and diabetes mellitus
Zip code
8188502
Address
1-1-1 Zokumyoin, Chikushino
TEL
+81929211011
Homepage URL
nihisak@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
Kunihisa Kobayashi
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nagasaki Prefecture Iki Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka University Chikushi Hospital (Fukuoka University)
Address
1-1-1 Zokumyoin, Chikushino, Fukuoka
Tel
+81929211011
nihisak@fukuoka-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
福岡大学筑紫病院（福岡県）、長崎県壱岐病院（長崎県）（IRB審査に関しては福岡大学で一括審査実施され、承認されている）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 04 | Day |
Related information
URL releasing protocol
https://journals.lww.com/md-journal/fulltext/2023/09220/investigation_of_the_metabolic_and.50.aspx
Publication of results
Published
Result
URL related to results and publications
https://journals.lww.com/md-journal/fulltext/2023/09220/investigation_of_the_metabolic_and.50.aspx
Number of participants that the trial has enrolled
11
Results
The results showed that BMI, HOMA-IR, FPG, and liver functions were significantly improved 6 months after switching compared to those at switching (each P < .05). Besides, the improvement in HOMA-IR was significantly associated with the period of daily GH replacement therapy before switching (P = .048), while the others were not associated. In addition, switching to GH replacement therapy did not affect endocrinological parameters.
Results date posted
| 2024 | Year | 07 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We investigated 11 individuals with AGHD at Fukuoka University Chikushi Hospital and Nagasaki Prefecture Iki Hospital. All patients had received daily GH replacement therapy for over 2 years and switched from daily GH replacement therapy to weekly GH replacement therapy with somapacitan between January 2022 and June 2022. The mean age was 61.9 +- 18.9 years, and 9 patients were female. Periods of GH replacement therapy were 6.9 +- 2.9 years.
Participant flow
We investigated the changes of parameters in the patients (11 patients) who were administered and continued treatment with somapacitan for 6 months in patients with AGHD previously receiving daily GH replacement therapy.
Adverse events
None.
Outcome measures
The changes of parameters (i.e. body mass index) in the patients between before changing and 6 months after changing.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 11 | Month | 16 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 17 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 01 | Month | 02 | Day |
Last modified on
| 2025 | Year | 01 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056894
