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) studied | Type 2 Diabetes Mellitus |
| Date of first enrollment | 01/04/2025 |
| Target sample size | 40 |
| Countries of recruitment | |
| Study type | Interventional |
| 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 Outcome | Change in blood glucose levels after consuming low-carb or high-carb desserts(intergroup comparison). |
|---|---|
| Secondary Outcome | Satisfaction and appetite suppression effects after consuming low-carb or high-carb desserts. |
Key inclusion & exclusion criteria
| Age minimum | >= 18age old |
|---|---|
| Age maximum | Not applicable |
| Gender | Both |
| Include criteria | Individuals 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 criteria | Patients 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
| Primary Sponsor | Yamamoto Rima |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Chateraise Co.,Ltd,Chateraise Co.,Ltd |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Rima Yamamoto |
| Address | Shimokato 1110,chuo,Yamanashi Yamanashi Japan 409-3898 |
| Telephone | +81-55-225-3141 |
| 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 |
| yrima@yamanashi.ac.jp | |
| Affiliation | University Of Yamanashi Hospital |