Effects of Dotinurad on uric acid levels, insulin resistance, NAFLD, and inflammatory markers in Type 2 Diabetes: A Clinical Study.

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. - Clinical study of Dotinurad, a URAT1 inhibitor, on changes in serum uric acid levels and insulin resistance in patients with type 2 diabetes.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000056865

Enrollment

100

Registered

2025-02-01

Start date

2025-02-03

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hyperuricemia

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Change in serum uric acid levels from baseline to 24 weeks after initiation of urate transporter 1 (URAT1) inhibitor treatment.	—

Secondary

Measure	Time frame
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.)	—

Measure

Time frame

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.)

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Countries

Japan

Contacts

Public Contactmakoto ide

St. Mary's Hospital Diabetes Endocrinology

ma-ide@st-mary-med.or.jp0942-35-3322

Outcome results