Clinical study on effectiveness of diabetic diet containing rare sugar D-allulose in patients with type 2 diabetes

Not Applicable

• Conditions: type 2 diabetes

• Registration Number: JPRN-jRCTs061200022
• Lead Sponsor: Imachi Hitomi

Brief Summary

Peak postprandial blood glucose levels were compared using a continuous glucose monitoring in type 2 diabetic patients aged 20 years and older and 80 years and younger who consumed a hospital diabetic diet containing D-allulose. Consumption of a hospital diabetic diet containing D-allulose improved postprandial blood glucose levels in patients with type 2 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-14
• Study Completion: 2022-08-31
• Results First Posted: 2023-06-19
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Patients with type 2 diabetes whose age at the time of obtaining consent is 20 to 80 years old.
2. Hospitalized type 2 diabetic patients. (HbA1c 6.5% or more)
3. Patients with written informed consent to participate in this study.

Exclusion Criteria

1. Patients taking an a-glucosidase inhibitor
2. Patients with a history of serious side effects after taking D-allulose in the past
3. Pregnant, maternity, lactating or potentially pregnant women
4. Patients with severe renal impairment (serum creatinine level of 1.5 mg/dl or higher)
5. Patients with other serious complications
6. Patients participating in other trials
7. According to the opinion of the investigator, etc., if participation in the research does not maximize the benefit of the research target (such as impairing the welfare of the research target), or obstructing, limiting, or confusing the evaluation specific to the clinical research implementation plan. If it is determined to do.
8. Under the direction of the investigator, etc. or the conducting medical institution, the investigator of the investigator or the conducting medical institution directly involved in this research or other clinical research, or such employee or the investigator Family

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The postprandial blood glucose peak value is comparatively examined using a Flash Glucose Monitoring.

Secondary Outcome Measures

Name	Time	Method
AUC 2 hours after meal when using continuous blood glucose meter<br>Blood/urine D allulose concentration<br>Questionnaire of patient satisfaction including seasoning<br>Change in weight change<br>Control status of diabetes before and after ingestion of each diet group<br>Changes in various laboratory test values