NCT02446054CompletedNot Applicable
A Study to Evaluate the Effect of Musashino Diabetes Diet in Type II Diabetes Mellitus Disease
Celio Technology Inc.1 site in 1 country30 target enrollmentStarted: February 1, 2014Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- the change of glycosylated hemoglobin (HbA1c)
Study Overview
Brief Summary
Evaluation the change of patients' glycosylated hemoglobin (HbA1c) after 12 weeks diet control
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
One Arm Study
Experimental
provide Musashino T2DM diet for 12 weeks to T2DM patients, to evaluate the effect on glycosylated hemoglobin (HbA1c), progression and compliance during study period.
Intervention: Musashino T2DM diet (Dietary Supplement)
Outcomes
Primary Outcomes
the change of glycosylated hemoglobin (HbA1c)
Time Frame: 12 weeks
12 weeks diet control
Secondary Outcomes
- the change of patients' fasting blood Glucose(12 weeks)
- the change of patients' fasting serum C-peptide(12 weeks)
- the change of EuroQol EQ-5D questionnaire(12 weeks)
- the change of patients' fasting serum Insulin(12 weeks)
- the change of WHO-QoL questionnaire(12 weeks)
- the patients' compliance questionnaire(12 weeks)
Investigators
Study Sites (1)
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