A Study to Evaluate the Effect of Musashino Diabetes Diet in Type II Diabetes Mellitus Disease

Study Overview
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Brief Summary
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Evaluation the change of patients' glycosylated hemoglobin (HbA1c) after 12 weeks diet control

Detailed Description
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In this study, we provide the delivery service of Musashino T2DM diet for 12 weeks to patients with T2DM, to evaluate the effect on glycosylated hemoglobin (HbA1c), progression and compliance during study period.

Official Title
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A Study to Evaluate the Effect of Musashino Diabetes Diet in Type II Diabetes Mellitus Disease

Conditions
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Type II Diabetes Mellitus

Intervention / Treatment
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* Dietary Supplement: Musashino T2DM diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A baseline of glycosylated hemoglobin(HbA1c) is, 10%≥HbA1c≥7%, during past 1 month The subject is able to understand and comply with protocol requirements, instrument The subject and/or subject's primary caregiver is able to have the telephone interview use computer and internet assess Signed and dated written informed consent Exclusion Criteria: Pregnancy, breastfeeding or planning to become pregnant during the study Acute illness or infection requiring treatment within 14 days of study entry Other serious disease (e.g. Heart, lung, brain, liver) within 3 months Presence of malignancies Participate in other clinical trial within 30 days prior to this study Alcohol or drug abuse that would interfere with the ability to meet study requirements (opinion of investigator) Concurrent significant medical condition that would limit ability to participate in the study Consider by the investigator to be unsuitable for study participation, for any reason

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: One Arm Study<br>provide Musashino T2DM diet for 12 weeks to T2DM patients, to evaluate the effect on glycosylated hemoglobin (HbA1c), progression and compliance during study period. | Dietary Supplement: Musashino T2DM diet<br>* provide Musashino T2DM diet for 12 weeks to T2DM patients, to evaluate the effect on glycosylated hemoglobin (HbA1c), progression and compliance during study period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change of glycosylated hemoglobin (HbA1c) | 12 weeks diet control | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change of patients' fasting blood Glucose |  | 12 weeks | 
| the change of patients' fasting serum Insulin |  | 12 weeks | 
| the change of patients' fasting serum C-peptide |  | 12 weeks | 
| the change of EuroQol EQ-5D questionnaire |  | 12 weeks | 
| the change of WHO-QoL questionnaire |  | 12 weeks | 
| the patients' compliance questionnaire |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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T2DM, type II diabetes Mellitus, HbA1c