UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046952 |
|---|---|
| Receipt number | R000053546 |
| Scientific Title | Comparison of muscle strength, cognitive ability, and sleep quality before and after switching to the somapacitan and with somatropin for patients with adult growth hormone deficiency during daily administration of the somatropin preparation (single-facility, observational study) |
| Date of disclosure of the study information | 2022/03/28 |
| Last modified on | 2023/08/23 11:01:01 |
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Basic information
Public title
Comparison of muscle strength, cognitive ability, and sleep quality before and after switching to the somapacitan once-weekly preparation and with the continuous daily administration of the somatropin preparation for patients with adult growth hormone deficiency during daily administration of the somatropin preparation (single-facility, observational study)
Acronym
Effects of Somapacitan once-weekly formulation on muscle strength, cognitive ability, and sleep quality
Scientific Title
Comparison of muscle strength, cognitive ability, and sleep quality before and after switching to the somapacitan and with somatropin for patients with adult growth hormone deficiency during daily administration of the somatropin preparation (single-facility, observational study)
Scientific Title:Acronym
Effects of Somapacitan on muscle strength, cognitive ability, and sleep quality
Region
| Japan |
Condition
Condition
Adult Growth Hormone deficiency
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For adult growth hormone deficiency (AGHD) patients who have been using Daily GH preparations, those who switched to Weekly GH therapy (Somapacitan) in their clinical practice, and those who continued to use Daily GH therapy (Somatropin). To clarify whether there is a difference between Weekly and Daily GH therapy in the effect of improvement on muscle strength and sleep quality and cognitive ability.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Lean body mass measured by DEXA
Key secondary outcomes
1. Muscle mass; raw electrical impedance value, limb circumference
2. Muscle strength; microFET (Force Evaluation and Testing), TUG test, muscle strength measured by walking for 6 minutes, muscle strength by measuring device, hand grip strength
3. Cognitive ability, depression; GDS-J, MOCA-J, Yaruki score
4. Sleep Assessment; Athens Insomnia Scale, Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, Sleep Cycle, etc.
Sleep measurement app
5. Glucose metabolism (FPG, F-IRI, HbA1c)
6. Lipid profile, Apo protein, Lpa,
7. QoL Questionnaire (AHQ, SF36)
8. Body composition (DEXA, waist circumference), Fat scan
9. Bone density (DEXA), bone metabolism marker
10. Arteriosclerosis (CAVI, Carotid Echo)
11. Fib4 index
12. Adherence; Judgment based on changes in serum IGF-I level, Moriski Medication Scale
13. Other unknown biomarkers (search blood sampling; metabolomics analysis, exosome analysis, gene expression analysis)
Before and after switching to Somapacitan, confirm the transition in the daily administration group of somatropin preparation during the same period.
Metabolome analysis is requested to the Mass Analysis Center, exosome analysis is outsourced to a company after extracting exosomes in our laboratory, miRNA, mRNA, protein expression is measured and analyzed in the laboratory, gene expression analysis is a blood sample. Analyze gene expression (mRNA) using.
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
Daily GH formulations
1. Patients who have already been treated with Daily GH formulations under the diagnosis of AGHD
2. Patients who do not wish to switch to Weekly GH formulations (Somapacitan)
3. Patients who have voluntarily consented to the document regarding participation in this study.
Weekly GH formulations
1. Patients who have already been treated with Daily GH formulations under the diagnosis of AGHD
2. Patients who wish to switch to Weekly GH formulations (Somapacitan) administration
3. Patients who have voluntarily consented to the document regarding participation in this study.
Key exclusion criteria
1. Patients with severe renal dysfunction (eGFR less than 30 mL / min / 1.73 m2)
2. Pregnant and lactating patients
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Fukuoka |
| Middle name | |
| Last name | Hidenori |
Organization
Kobe University Hospital
Division name
Diabetes and Endocrinology
Zip code
6500017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe
TEL
0783825861
fukuokah@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Fukuoka |
| Middle name | |
| Last name | Hidenori |
Organization
Kobe University Hospital
Division name
Diabetes and Endocrinology
Zip code
6500017
Address
7-5-2 Kusunoki-cho, Cuo-ku, Kobe
TEL
0783825861
Homepage URL
fukuokah@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Undecided
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
Kobe University Hospital IRB office
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe
Tel
078-382-6669
kansatsu@med.kobe-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
| 2022 | Year | 03 | Month | 28 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 28 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2022 | Year | 02 | Month | 20 | Day |
Last modified on
| 2023 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053546
