UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056865 |
|---|---|
| Receipt number | R000064774 |
| Scientific Title | Clinical study of Dotinurad, a Uric Acid transporter 1 (URAT1) inhibitor, on changes in serum uric acid levels, insulin resistance, NAFLD, and inflammatory markers in patients with type 2 diabetes. |
| Date of disclosure of the study information | 2025/02/01 |
| Last modified on | 2025/02/13 16:15:50 |
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Basic information
Public title
Effects of Dotinurad on uric acid levels, insulin resistance, NAFLD, and inflammatory markers in Type 2 Diabetes: A Clinical Study.
Acronym
Effects of Dotinurad on uric acid levels and insulin resistance in Type 2 Diabetes: A Clinical Study.
Scientific Title
Clinical study of Dotinurad, a Uric Acid transporter 1 (URAT1) inhibitor, on changes in serum uric acid levels, insulin resistance, NAFLD, and inflammatory markers in patients with type 2 diabetes.
Scientific Title:Acronym
Clinical study of Dotinurad, a URAT1 inhibitor, on changes in serum uric acid levels and insulin resistance in patients with type 2 diabetes.
Region
| Japan |
Condition
Condition
hyperuricemia
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effect of a urate transporter 1 (URAT1) inhibitor (dotinurad) on uric acid levels in type 2 diabetic patients with hyperuricemia. We will also identify changes in various metabolic markers involved in the underlying disease associated with hyperuricemia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in serum uric acid levels from baseline to 24 weeks after initiation of urate transporter 1 (URAT1) inhibitor treatment.
Key secondary outcomes
Change from baseline to the start of urate transporter 1 (URAT1) inhibitor administration, 6, 12, and 24 weeks for the following items
1. Uric acid excretion rate (uric acid, urinary Cr, serum uric acid, serum Cr)
2. glucose metabolism (fasting blood glucose, HbA1c, HOMA-R, CPR, CPI)
3. complete blood count
4. Serum lipids (LDL-C, HDL-C, TG, fatty acid fraction)
5. Liver function (T-Bil, AST, ALT, gamma-GTP, Fib4 index, NAFLD fibrosis score, M2BPGi)
6. Renal function (Cr, eGFR, UACR, cystatin C, L-FABP)
7. Cardiac function (NT-proBNP)
8. Inflammation-related markers (CRP, Ferritin)
9. neuropathy (nerve conduction studies)
10. BMI, blood pressure, pulse rate
11. Body composition (Inbody)
12. Inflammatory cytokines (IL-6, TNFa, MCP-1, IL-1b, etc.)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Those who present serum uric acid level of 7 mg/dL or higher
(2) Patients with type 2 diabetes mellitus with HbA1c less than 10
(3) Patients who are at least 20 years of age and have given written consent to participate in this study.
(If the patient has dementia, written consent must be obtained from a surrogate.)
(4) Patients who have not changed concomitant hypoglycemic or antihypertensive medication in the past 3 months.
(5) Blood and urine samples can be obtained at follow-up before and after the intervention.
(6) Patients whose written consent has been obtained.
Key exclusion criteria
(1) Those with active gouty arthritis
(2) Those with urinary tract stones
(3) Those who are pregnant or lactating
(4) Others whom the principal investigator and research assistants deem medically inappropriate as research subjects.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | nao |
| Middle name | |
| Last name | hasuzawa |
Organization
Kurume University
Division name
Department of Medicine, Chair of Internal Medicine, Division of Endocrine and Metabolic Medicine
Zip code
830-0011
Address
67 Asahi-cho, Kurume-shi, Fukuoka
TEL
0942-31-7563
hasuzawa@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | makoto |
| Middle name | |
| Last name | ide |
Organization
St. Mary's Hospital
Division name
Diabetes Endocrinology
Zip code
830-8543
Address
422, Tsufuku Honmachi, Kurume-shi, Fukuoka
TEL
0942-35-3322
Homepage URL
ma-ide@st-mary-med.or.jp
Sponsor or person
Institute
Kurume University
Institute
Department
Personal name
nao hasuzawa
Funding Source
Organization
None
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
Kurume University
Address
67 Asahi-cho, Kurume-shi, Fukuoka
Tel
0942-35-3311
i_rinri@kurume-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
| 2025 | Year | 02 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 01 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 02 | Month | 03 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: cohort study
Method of recruitment of subjects: all patients who visited our institution between February and December 2025 and met the selection criteria
Management information
Registered date
| 2025 | Year | 01 | Month | 29 | Day |
Last modified on
| 2025 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064774
