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)

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) - Effects of Somapacitan on muscle strength, cognitive ability, and sleep quality

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000046952

Enrollment

Registered

2022-03-28

Start date

2022-03-28

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult Growth Hormone deficiency

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: 1. Patients with severe renal dysfunction (eGFR less than 30 mL / min / 1.73 m2) 2. Pregnant and lactating patients

Design outcomes

Primary

Measure	Time frame
Lean body mass measured by DEXA	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Japan

Contacts

Public ContactFukuoka Hidenori

Kobe University Hospital Diabetes and Endocrinology

fukuokah@med.kobe-u.ac.jp0783825861

Outcome results