NIPH Clinical Trials Search

JAPANESE
JRCT ID: jRCT1031250027

Registered date:25/04/2025

Evaluation of Postprandial Blood Glucose Management and Appetite Suppression Effects in Diabetic Patients Using Low-Carbohydrate Desserts

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedType 2 Diabetes Mellitus
Date of first enrollment01/04/2025
Target sample size40
Countries of recruitment
Study typeInterventional
Intervention(s)The allocation of each group of study participants will be done using a stratified random block method.Participants will be randomly assigned to either "Group1"or"Group2". After hospitalization,participants will receive an explanation and obtain consent,followed by the application of FreeStyle Libre2. If fasting blood glucose remains below 150mg/dL for two consecutive days,the participant will be considered to have stable blood glucose,and dessert will be provided starting the following day. Desserts will be provided two hours after the start of lunch."Group1"will consume a "low-carb dessert" on Day1,while "Group2" will consume a "high-carb dessert". On Day2, "Group1" will consume a "high-carb dessert",and "Group2" will consume a "low-carb dessert" The number of servings of low-carb and high-carb desserts will be adjusted to be equal. After dinner,blood glucose fluctuations will be analyzed using LibreView(30 minutes,1hour,and 2hours post-meal),and a questionnaire on satisfaction and appetite suppression effects will be conducted. To avoid affecting satisfaction,neither group will be informed whether they are consuming "low-carb"or"high-carb" desserts during the measurement. Questionnaire:Satisfaction and appetite suppression effects after consuming low-carb or high-carb desserts. The questionnaire will be filled out on paper or via Gogle Forms. The time required to complete the questionnaire is approximately 5-10 minutes per response.

Outcome(s)

Primary OutcomeChange in blood glucose levels after consuming low-carb or high-carb desserts(intergroup comparison).
Secondary OutcomeSatisfaction and appetite suppression effects after consuming low-carb or high-carb desserts.

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteriaIndividuals who have received a sufficient explanation of the purpose and content of this study,have the capacity to consent,fully understand the study,and voluntarily agreed to participate inwriting Individuals who were 18 years or older at the time of obtaining consent Patients with type2diabetes who were diagnosed with diabetes and hospitalized for diabetes education after visiting the department of diabetes and endocrinology at University of Yamanashi Hospital between april 2025 and september 2025 Regardless of gender
Exclude criteriaPatients who have difficulty completing the questionnaire Patients who have difficulty communicating in Japanese Patients for whom participation is deemed inappropriate by the researcher due to significant physical or psychological burden Patients with food allergies Patients with implanted medical devices such as pacemakers Patients deemed unsuitable for inclusion based on the physicians's judgment

Related Information

Contact

Public contact
Name Rima Yamamoto
Address Shimokato 1110,chuo,Yamanashi Yamanashi Japan 409-3898
Telephone +81-55-225-3141
E-mail yrima@yamanashi.ac.jp
Affiliation University Of Yamanashi Hospital
Scientific contact
Name Rima Yamamoto
Address Shimokato 1110,chuo,Yamanashi Yamanashi Japan 409-3898
Telephone +81-55-273-1111
E-mail yrima@yamanashi.ac.jp
Affiliation University Of Yamanashi Hospital