UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044989 |
|---|---|
| Receipt number | R000051398 |
| Scientific Title | Somatropin effects on liver fat content in AGHD patients-a single centre non-interventional study |
| Date of disclosure of the study information | 2021/07/29 |
| Last modified on | 2025/01/10 23:46:41 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Somatropin effects on liver fat content in AGHD patients-a single centre non-interventional study
Acronym
GH effects on liver fat content in patients with AGHD
Scientific Title
Somatropin effects on liver fat content in AGHD patients-a single centre non-interventional study
Scientific Title:Acronym
GH effects on liver fat content in patients with AGHD
Region
| Japan |
Condition
Condition
Adult growth hormone deficiency
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
There is currently an evidence gap on the effects of GHT on liver fat content and liver function (including effects on NAFLD) as a combined retrospective and prospective observational study to confirm hypothesis of effectiveness of GHT on hepatic fat content and liver function in AGHD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Prospective group: Change in Hepatic Fat Fraction measured by IDEAL IQ method of liver MRI at the beginning of the study and after 6 months.
Retrospective group: Change in Hepatic Fat Fraction measured by IDEAL IQ of liver MRI at study entry, 6 months, or later.
Key secondary outcomes
1. Change in body weight at the beginning of the study, 6 months later in the prospective group, and 6 months later or later in the retrospective group
2. Change in the liver-related enzyme at study entry and after 6 months in the prospective group and after 6 months or later in the retrospective group.
3. Presence of NAFLD assessed at study entry and after 6 months in the prospective group and after 6 months or later in the retrospective group.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
AGHD patients who are treated in Kitasato university between April 1st, 2010 and March 31st,2023.
Key exclusion criteria
1, Patients before and after surgery or with severe trauma
2, Patients with excessive alcohol intake. Estimated ethanol equivalent based on the patient's self-report; 30 g/day for men, 20g /day or more for women
3, Patients with undeniable complications of other liver diseases, including viral hepatitis, autoimmune hepatitis, and drug-induced hepatitis.
4, Patients with severe hepatic impairment, cirrhosis of the liver of Child-Pugh classification B or C
5, Patients with hepatitis virus infection
6, Patients with an apparent malignant tumor
7, Women who are pregnant or may become pregnant
8, Under 20 years old and over 80 years old
9, Patients with mental retardation or linguistic problems that prevent them from fully understanding the research content
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tomomi |
| Middle name | |
| Last name | Taguchi |
Organization
Kitasato University School of Medicine
Division name
Department of Endocrinology, Metabolism & Diabetes
Zip code
252-0375
Address
1-15-1 Kitasato, Minami-ku Sagamihara
TEL
0427788111
t.tomo@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomomi |
| Middle name | |
| Last name | Taguchi |
Organization
Kitasato University School of Medicine
Division name
Department of Endocrinology, Metabolism & Diabetes
Zip code
252-0375
Address
1-15-1 Kitasato, Minami-ku Sagamihara
TEL
0427788111
Homepage URL
t.tomo@kitasato-u.ac.jp
Sponsor or person
Institute
Department of Endocrinology, Metabolism & Diabetes, Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Novo Nordisk Pharma Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of the Kitasato University School of Medicine
Address
1-15-1 Kitasato, Minami-ku Sagamihara
Tel
042-778-8111
rinrib@med.kitasato-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
| 2021 | Year | 07 | Month | 29 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/endocrj/advpub/0/advpub_EJ24-0481/_article
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/endocrj/advpub/0/advpub_EJ24-0481/_article
Number of participants that the trial has enrolled
30
Results
Effect of GH replacement therapy on hepatic lipid content Hepatic lipid content in the GHRT group, as measured by MRI-PDFF, was significantly reduced at the last visit compared with at baseline (p = 0.041).
Results date posted
| 2025 | Year | 01 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 01 | Month | 09 | Day |
Baseline Characteristics
Thirty people with AGHD were recruited for this　study
Participant flow
Some patients in the GHT and No GHT groups will be prospectively followed and data will be collected from the medical records at baseline and approximately 6 months after enrolment, according to normal clinical practice. If GH treatment already started and patients are either still on GH treatment or have completed at the time of study start, all data will be collected retrospectively from available medical records for the duration of GH therapy. In case of any clinic visits in between, data should also be collected.Some patients in the No GHT group are under an ongoing follow-up without GH treatment and data will be collected from available medical records at baseline and approximately 6 months after baseline data collection. If longer follow up data are available, these may be collected as well.For all patients who are not prospectively entering the study, baseline data to evaluate liver function before GH initiation / non-GHT follow up are required to be eligible for inclusion. The data collection period varies for these patients as the treatment duration after starting GH treatment varies between patients and only patients with an expected total GH treatment duration of 6 months or more after GH start are eligible for inclusion.
Adverse events
A subject assigned to the GHRT group was excluded from the study owing to drug-induced liver injury, which was presumably not associated with GHRT.
Outcome measures
Primary endpoint: Change in hepatic fat content from baseline to end of study
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 06 | Month | 29 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 29 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 26 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 07 | Month | 28 | Day |
Last modified on
| 2025 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051398
