Study on the effects of GLP1 on hepatic lipid content in AGHD complicated with obesity

JRCT ID: jRCT1031240227

Registered date:23/07/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Adult growth hormone deficiency
• Date of first enrollment: 23/07/2024
• Target sample size: 20
• Study type: Observational
• Intervention(s): none

Outcome(s)

• Primary Outcome: The change in hepatic fat content (MRI-PDFF) from the beginning to the end of the study

Secondary Outcome

1, The changes in parameters related to body composition from the beginning to the end of the study.
2, The changes in parameters related to each blood test item from the beginning to the end of the study.
3, The correlation between the change in MRI-PDFF and each parameter.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old

Include criteria

1, Severe Adult growth hormone deficiency
2, Patients scheduled for Wegovy administration with an indication for its use,
3, BMI of 27 kg/m2 or higher with at least two obesity-related health disorders, or a BMI of 35 kg/m2 or higher
4, Receiving nutritional counseling for more than 6 months
5, Undergoing growth hormone replacement therapy

Exclude criteria

1, Patients with severe trauma or undergoing surgery
2, Excessive alcohol consumers (estimated ethanol intake more than 30 g/day for men, and more than 20 g/day for women)
3, Patients with other liver diseases that cannot be ruled out, including viral hepatitis, autoimmune hepatitis, and drug-induced hepatitis
4, Patients with severe liver disfunction or liver cirrhosis classified as Child-Pugh B or C
5, Patients infected with the hepatitis virus
6, Patients with obvious malignant tumors
7, Pregnant women or women who might be pregnant
8, Patients using implanted medical devices (such as pacemakers)
9, Individuals under 20 years old or over 80 years old
10, Patients with intellectual disabilities or language problems that prevent them from fully understanding the study
11, Patients who are judged to be unable to carry out this study by the principal investigator or research assistant.

Related Information

• Primary Sponsor: Taguchi Tomomi