UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056120 |
|---|---|
| Receipt number | R000062893 |
| Scientific Title | Study of the effect of diabetes medications on alcohol consumption and liver fat content in patients with type 2 diabetes mellitus complicated by fatty liver disease |
| Date of disclosure of the study information | 2024/11/13 |
| Last modified on | 2024/11/11 15:52:09 |
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Basic information
Public title
Study of the effect of diabetes medications on alcohol consumption and liver fat content in patients with type 2 diabetes mellitus complicated by fatty liver disease
Acronym
The effect of diabetes medications on alcohol consumption and liver fat content in patients with type 2 diabetes mellitus complicated by fatty liver disease
Scientific Title
Study of the effect of diabetes medications on alcohol consumption and liver fat content in patients with type 2 diabetes mellitus complicated by fatty liver disease
Scientific Title:Acronym
The effect of diabetes medications on alcohol consumption and liver fat content in patients with type 2 diabetes mellitus complicated by fatty liver disease
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus complicated by fatty liver
Classification by specialty
| Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The incidence of cirrhosis in Japan continues to decrease in viral, especially HCV. On the other hand, the incidence of cirrhosis caused by alcoholic and non-alcoholic fatty liver disease trends to increase. It has been reported that type 2 diabetes mellitus is the most important factor involved in the progression from fatty liver to liver fibrosis, cirrhosis, and the development of hepatocellular carcinoma. Pioglitazone, SGLT2 inhibitors, and GLP-1 receptor agonists are the treatment options for non-alcoholic fatty liver associated with type 2 diabetes. Tilzepatide, which has a sustained effect on GIP receptors in addition to GLP-1 receptors, has become available and is expected to have an effect on blood glucose and weight loss. The recent study have also reported that the effect of appetite suppression by tilzepatide may also reduce alcohol consumption. If we can demonstrate that diabetes medications, including tilzepatide, reduces alcohol consumption and hepatic fat content, further intervention in fatty liver associated with type 2 diabetes mellitus may be possible.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in liver fat content, HbA1c, and BMI at 36 weeks from baseline
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Type 2 diabetes patients who start on tirzepatide (SGLT2 inhibitors, GLP-1 receptor agonists, DPP-4 inhibitors, and metformin are also included in the study population in the same process)
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetes patients over 20 years old with fatty liver detected by abdominal echo or CT scan within 1 year of study entry.
Key exclusion criteria
Alcohol consumption exceeding 20g for women or 30g for men per day.
Pregnant women.
Contraindication to MRI.
BMI less than 18 kgm2.
SGLT2 inhibitors were excluded if they were started within 1 year of study entry.
Other diabetes medications were excluded for those starting within 8 weeks of study entry.
Severe renal or hepatic disease.
Other chronic liver disease.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Akihisa |
| Middle name | |
| Last name | Hidaka |
Organization
JCHO Tokyo Yamate Medical Centre
Division name
Department of Diabetes and Endocrinology
Zip code
169-0073
Address
3-22-1 Hyakunin-cho, Shinjuku-ku Tokyo, Japan
TEL
03-3364-0251
akihisahidaka@gmail.com
Public contact
Name of contact person
| 1st name | Akihisa |
| Middle name | |
| Last name | Hidaka |
Organization
JCHO Tokyo Yamate Medical Centre
Division name
Department of Diabetes and Endocrinology
Zip code
169-0073
Address
3-22-1 Hyakunin-cho, Shinjuku-ku Tokyo, Japan
TEL
03-3364-0251
Homepage URL
akihisahidaka@gmail.com
Sponsor or person
Institute
JCHO Tokyo Yamate Medical Centre
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
JCHO Tokyo Yamate Medical Centre
Address
3-22-1 Hyakunin-cho, Shinjuku-ku Tokyo, Japan
Tel
03-3364-0251
akihisahidaka@gmail.com
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
| 2024 | Year | 11 | Month | 13 | 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
| 2024 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 11 | Day |
Last modified on
| 2024 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062893
