Type 2 Diabetes Mellitus
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients providing written informed consent to participate in the study 2.Aged >=20 years (irrespective of sex) 3.Serum uric acid level >6.0, <10.0 mg/dL at consent 4.A >0.5 mg/dL increase in serum uric acid level at consent compared to before that (2-6 weeks before consent)or serum uric acid level >=7.0 mg/dL both before and at consent 5.Patients who have not administration of drugs for hyperuricemia from at least 6 weeks before the date of consent 6.50% of total energy from carbohydrate and patients who have not intake barley at consent
Exclusion criteria
Exclusion criteria: 1.Type 1 diabetes 2.Patients with severe ketosis, diabetic coma or pre-coma, severe infection, perioperative, or severe trauma 3.Patients with severe renal dysfunction or treated with hemodialysis for end-stage renal disease 4.History of acute coronary syndrome, cerebrovascular disease, myocarditis, contractile pericarditis, or severe valvular disease within 12 weeks before consent 5.Patients with liver dysfunction (AST or ALT >100IU/L) or urolithiasis 6.Diagnosed or suspected malignant tumors (patients who do not have a treatment history of anticancer therapy within 1 year before consent, and have no plan to do so will not be excluded) 7.Pregnant, breast-feeding, or possibly pregnant women 8.Patients treated with SGLT2 inhibitor, losartan, or irbesartan within 6 weeks before consent 9.Patients in the study is judged by the investigator or sub-investigator as inappropriate for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of serum uric acid and carbohydrate energy ratio at 12 weeks after barley intake | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes of several parameters at 4, 8, and 12 weeks after barley intake as shown below | — |
Countries
Japan
Contacts
Nakakinen clinic Department of clinical research