The blood glucose fluctuation difference between weekly GH replacement and daily GH replacement

JRCT ID: jRCT1031210321

Registered date:16/09/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Adult grwoth hormone deficiency
• Date of first enrollment: 10/12/2021
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Treatment will be continued with the daily GH injection that has been used for the first 2 weeks of the study, and the daily GH injection will be discontinued and Sogroya will be started 2 weeks and 3 or 4 days after the start of the study. Sogroya will be used as indicated. FGM will be used for a total of 4 weeks which includes two weeks at the start of the study and two weeks between 14-18 weeks after the start of the study.

Outcome(s)

• Primary Outcome: Comparing the difference in MAGE between Daily GH replacement and weekly GH replacement.

Secondary Outcome

Comparing the difference in HbA1c, GA, fasting glucose between Daily GH replacement and weekly GH replacement.
Comparing the difference in the body composition between Daily GH replacement and weekly GH replacement.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 60age old
• Gender: Both

Include criteria

The patients who undertake Daily GH replacement (norditropin, humatrope, genotropin, growject) from the Hospital director's permission date by March 31 st, 2023 are going to undergo sogroya.
The administration condition of GH preparation is limited to patients diagnosed with severe adult growth hormone deficiency. Diagnosis of adult growth hormone deficiency (AGHD) as per Japanese practice

Exclude criteria

Before undertaking operations or presence of severe trauma.
Presence of malignant tumor(s).
Pregnant or likely to get pregnant.
Diabetes mellitus.
age: less than 20 years old or more than 60 years old

Related Information

• Primary Sponsor: Miyatsuka Takeshi
• Source(s) of Monetary Support: The Foundation for Growth Science