MARIA19-09T

Phase 3

• Conditions: type 2 diabetes mellitus

• Registration Number: JPRN-jRCTs031200008
• Lead Sponsor: akamura Yuta

Brief Summary

For patients with type 2 diabetes, OIST rice significantly reduced postprandial blood glucose compared to white rice. The improvement in blood glucose was not accompanied by an increase in insulin and incretin. In addition, insulin, blood C-peptide, and total GIP were significantly reduced. Therefore, for patients with type 2 diabetes, OIST rice obtained improvement in blood glucose independent of insulin secretion as compared with white rice.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-10
• Study Completion: 2021-03-18
• Results First Posted: 2023-04-11
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 20

Inclusion 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.

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified