UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046797 |
|---|---|
| Receipt number | R000053394 |
| Scientific Title | A potent efficacy of pioglitazone on alcoholic and non-alcoholic fatty liver disease in type 2 diabetic mellitus |
| Date of disclosure of the study information | 2022/02/01 |
| Last modified on | 2023/04/27 17:13:21 |
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Basic information
Public title
A potent efficacy of pioglitazone on alcoholic and non-alcoholic fatty liver disease in type 2 diabetic mellitus
Acronym
A potent efficacy of pioglitazone on alcoholic and non-alcoholic fatty liver disease in type 2 diabetic mellitus
Scientific Title
A potent efficacy of pioglitazone on alcoholic and non-alcoholic fatty liver disease in type 2 diabetic mellitus
Scientific Title:Acronym
A potent efficacy of pioglitazone on alcoholic and non-alcoholic fatty liver disease in type 2 diabetic mellitus
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of pioglitazone for type 2 diabetic patients with fatty liver, according to the cause of fatty liver and the dose of pioglitazone
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The changes of liver enzymes such as AST, ALT and g-GTP in three months after the administration of pioglitazone
Key secondary outcomes
The changes of HbA1c and FIB-4 Index in three months after the administration of pioglitazone
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetic patients who had newly prescribed pioglitazone from October 2015 to September 2020
Key exclusion criteria
Patients who refused to participate in this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Asakawa |
Organization
Tokyo Teishin Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
102-0071
Address
2-14-23, Fujimi, Chiyoda-ku, Tokyo, Japan
TEL
03-5214-7111
m.asakawa@tth-japanpost.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Asakawa |
Organization
Tokyo Teishin Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
102-0071
Address
2-14-23, Fujimi, Chiyoda-ku, Tokyo, Japan
TEL
03-5214-7111
Homepage URL
m.asakawa@tth-japanpost.jp
Sponsor or person
Institute
Tokyo Teishin Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokyo Teishin Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Teishin Hospital
Address
2-14-23, Fujimi, Chiyoda-ku, Tokyo, Japan
Tel
03-5214-7111
m.asakawa@tth-japanpost.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
東京逓信病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
https://doi.org/10.1007/s13340-023-00619-z
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1007/s13340-023-00619-z
Number of participants that the trial has enrolled
100
Results
In patients with fatty liver, the HbA1c, AST, ALT, and gGTP levels significantly decreased after pioglitazone treatment than before (P<0.01). The AST and ALT levels, but not the gGTP level, and the FIB-4 index significantly decreased after pioglitazone addition in the AFLD group, similar to that in the NAFLD group (P<0.05 and P<0.01, respectively). Similar effects were observed following low-dose pioglitazone treatment (below 7.5 mg/day) (P<0.05) in T2D patients with AFLD and NAFLD.
Results date posted
| 2023 | Year | 04 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
In this study, 100 patients with T2D who were newly prescribed pioglitazone and received it for at least 3 months by physicians at Tokyo Teishin Hospital in Tokyo, Japan between October 2015 and September 2020 were selected. Patients with hepatitis virus, autoimmune hepatitis, and severe renal failure (i.e., an estimated glomerular filtration rate <30 mL/min/1.73 m2) were excluded.
Participant flow
The diagnosis of fatty liver was evaluated by radiologists using ultrasonography or computed tomography (CT). Alcohol consumption habits (alcohol consumption >30 g/day for men and >20 g/day for women) were investigated to distinguish between NAFLD and AFLD. According to this information, we divided the subjects into three categories; patients without fatty liver, patients with NAFLD and patients with AFLD.
Adverse events
Two patients who received the standard pioglitazone dose (1 with NAFLD and 1 without fatty liver) experienced edema of the lower extremities. No severe hypoglycemia or hyperglycemia was observed. Additionally, no other adverse effects related to the skin, gastrointestinal tract, urinary tract, bone metabolism, or fractures were observed during the study.
Outcome measures
Clinical data including age, sex, weight, the serum levels of AST, ALT, gGTP, and HbA1c, platelet count, pioglitazone dosage, and history of concomitant use of antidiabetic drugs other than pioglitazone were collected from the patient medical records. Changes in clinical parameters between pre-treatment and 3 months after pioglitazone administration were evaluated in patients with or without fatty liver and in those with AFLD or NAFLD. Changes in HbA1c levels were also compared between patients with and without fatty liver. To evaluate the efficacy of pioglitazone based on the dosage, the pioglitazone dose was divided into low dose and standard dose.
The degree of liver fibrosis was determined using the FIB-4 index, which was validated for Japanese patients with NAFLD.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing particularly
Management information
Registered date
| 2022 | Year | 02 | Month | 01 | Day |
Last modified on
| 2023 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053394
