Type II Diabetes Mellitus
Conditions
Keywords
T2DM, type II diabetes Mellitus, HbA1c
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.
Interventions
DIETARY_SUPPLEMENTMusashino T2DM diet
provide Musashino T2DM diet for 12 weeks to T2DM patients, to evaluate the effect on glycosylated hemoglobin (HbA1c), progression and compliance during study period.
Sponsors
Celio Technology Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the change of glycosylated hemoglobin (HbA1c) | 12 weeks | 12 weeks diet control |
Secondary
| Measure | 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 |
Countries
Taiwan
Outcome results
None listed