NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs061200022

Registered date:14/10/2020

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

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedtype 2 diabetes
Date of first enrollment03/12/2020
Target sample size24
Countries of recruitment
Study typeInterventional
Intervention(s)A: Diabetes diet precedent group After being hospitalized, eat a diabetic diet three times a day for two days. After a washout period of 1 day, a rare sugar-containing diabetic diet is taken 3 times a day for 2 days. The rare sugar-containing diabetic diet contains 8.5 g of D-allulose per serving. B: Rare sugar-containing diabetic diet precedent group After being hospitalized, take a diabetic diet containing rare sugars 3 times a day for 2 days. After a washout period of 1 day, eat a diabetic diet 3 times a day for 2 days. The rare sugar-containing diabetic diet contains 8.5 g of D-allulose per serving.

Outcome(s)

Primary OutcomeThe postprandial blood glucose peak value is comparatively examined using a Flash Glucose Monitoring.
Secondary OutcomeAUC 2 hours after meal when using continuous blood glucose meter Blood/urine D allulose concentration Questionnaire of patient satisfaction including seasoning Change in weight change Control status of diabetes before and after ingestion of each diet group Changes in various laboratory test values

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 80age old
GenderBoth
Include criteria1. 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.
Exclude criteria1. 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

Related Information

Contact

Public contact
Name Kensaku Fukunaga
Address 1750-1,Miki-cho, Kita-gun Kagawa Japan 761-0793
Telephone +81-87-891-2230
E-mail fukunaga.kensaku@kagawa-u.ac.jp
Affiliation Kagawa University hospital
Scientific contact
Name Hitomi Imachi
Address 1750-1,Miki-cho, Kita-gun Kagawa Japan 761-0793
Telephone +81-878912230
E-mail imachi.hitomi@kagawa-u.ac.jp
Affiliation Kagawa University hospital