MARIA19-09T

JRCT ID: jRCTs031200008

Registered date:10/04/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: type 2 diabetes mellitus
• Date of first enrollment: 26/05/2020
• Target sample size: 30
• Study type: Interventional
• Intervention(s): For breakfast, subjects ingest 150g of OIST rice or white rice on separate days after overnight fast. Each test day has an interval of 1-3 days.

Outcome(s)

• Primary Outcome: total AUC0-240min - glucose

Secondary Outcome

incremental AUC0-240min - glucose
total AUC0-240min - insulin
incremental AUC0-240min - insulin
total AUC0-240min - total GLP-1
incremental AUC0-240min - total GLP-1
total AUC0-240min - total GIP
incremental AUC0-240min - total GIPpreference questionnaire

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients who are admitted to the Department of Metabolism and Endocrinology, St. Marianna University Hospital for improvement of glycemic control and meet the following criteria.
1. Patients with insulin-independent type 2 diabetes mellitus ; fasting serum C-peptide>=0.6 ng/ml and GAD antibody negative.
2. Patients with a fasting blood glucose level of 54-300 mg/dL during the last 3 days.
3. Male or female over the age of 20 at the time of obtaining informed consent.
4. Patients who agreed to use the data of urine and blood tests ; Hgb, Hct, blood glucose, AST, ALT, Cre, BUN, UA, T-chol, HDL-chol, LDL-chol, TG, HbA1c, GA, C-peptide, urinary microalbumin.
5. Patients with written informed consent after receiving a full explanation.

Exclude criteria

1.Patients using any of the following diabetes treatments.
/DPP4 inhibitor
/GLP-1 receptor agonist
/alpha-glucosidase inhibitor
2.Patients who need more than 15 units of rapid-acting insulin in the morning when obtaining informed consent.
3.Patients with unstable oral intake.
4.Women who were pregnant, possibly pregnant, or were breastfeeding.
5.Menstrual period.
6.Rice allergy or brown rice allergy.
7.Patients who were considered to be ineligible for other reasons by the attending doctor.

Related Information

• Primary Sponsor: Nakamura Yuta
• Secondary Sponsor: NICHIREI CORPORATION