Type 2 diabetes mellitus
Conditions
Sponsors
EP Mediate Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Male and female who were diagnosed with type 2 diabetes mellitus more than one year ago and are 50 or more and under 75 years of age. (2) Subjects with HbA1c of 7% or more and less than 9% at the time of pre-examination. (3) Subjects with a BMI of 23 kg/m2 or more. (4) Subjects who have been receiving the same diabetes mellitus treatment for 3 months or more before the pre-examination. (5) Subjects who have agreed in writing to participate in the study and can be tested on the designated test date.
Exclusion criteria
Exclusion criteria: (1) Subjects who cannot continuously ingest research foods due to business trips etc. during the intake period. (2) Subjects receiving treatment with insulin preparations (including treatment within the past 3 months). (3) Patients with a history of severe hypoglycemia in the past. (4) Subjects with a history of proliferative retinopathy or more, or diabetic nephropathy stage III or more. (5) Subjects who self-reported a weight change of 5% or more within 3 months before the pre-examination. (6) Subjects with a history of myocardial infarction or stroke within the past year. (7) Subjects who are planning to change, add new or discontinue the treatment method for diabetes mellitus between the pre-examination and the intake start examination. (8) Subjects with food allergies. (9) Subjects with an average daily alcohol intake of more than 60 g. (10) Subjects with a smoking habit of more than 21 cigarettes per day. (11) Subjects who are judged by the principal investigator to be at risk of being hospitalized or having dietary restrictions etc. that may affect the continuation of the study or the intake of the research foods. (12) Subjects with diseases that may turn into serious adverse events during the study period, such as cancer. (13) Subjects who cannot properly store and ingest research foods due to reasons such as the inability to install a freezer to distribute and the lack of a microwave oven. (14) Subjects who cannot record diary or answer questionnaires on the Web. (15) Subjects with implantable medical devices such as cardiac pacemakers or life-sustaining medical devices such as biometric monitors. (16) Subjects who are planning to become pregnant or breastfeed during the study period. (17) Subjects who are participating in other clinical studies (including clinical trials) at the start of this study. (18) Subjects who are judged as unsuitable for the study by the investigator for other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c Evaluate before ingestion, 6 weeks and 12 weeks after ingestion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Medication effect score Fasting glucose level Physical measurement (body weight, BMI, abdominal circumference) Clinic blood pressure Body-fat percentage QOL examination Fasting clinical examination Evaluate before ingestion, 6 weeks and 12 weeks after ingestion. | — |
Countries
Japan
Contacts
Public ContactShingo Yamamichi
EP Mediate Co., Ltd. Foods Department, Trial Planning Section
Outcome results
None listed