type 2 diabetes patients type 2 diabetes patients,
Conditions
Interventions
Eligible subjects receiving study formula (Gen-
Premium) as a meal replacement of 30% of total energy requirement per day or normal diet until Day 90.,Eligible subjects receiving normal diet as recommended by nutritionist until Day 90.
Gen-
Premium Medical Food,Normal diet
Sponsors
Thai Otsuka Pharmaceutical Co., Ltd
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Diagnosed with type 2 DM at least 6 months 2. Age of 18 years and older 3. Subjects with HbA1C 7-9% 4. Subjects with weight changed less than 5% at least 3 months before enrollment 5. Subjects with dyslipidemia, continue stable dose of lipid lowering agent at least 3 months before enrollment 6. Subjects with diet control, insulin, hypoglycaemic agent at least 6 months with unchanged dose at least 3 months before enrollment 7. Willing to participate in the study and sign the inform consent form
Exclusion criteria
Exclusion criteria: 1. Subject with history of severe hypoglycemia with neuroglycopenia 2. Subject with severe complication; amputation, diabetic coma 3. Subject with history of GI dysfunction such as short bowel syndrome, colectomy 4. Subject with cardiovascular diseases; ischemic heart disease, stroke or history of heart failure within 6 weeks before enrollment 5. Subject with significant abnormal laboratory value such as hemoglobin 3 times upper limit of normal, total bilirubin > 2 times upper limit of normal 6. Subject with GFR < 60 mL/min/1.73m2 7. Subject with psychiatric disorder, alcoholism, drug addiction 8. Subject with active thyroid dysfunction 9. Subject with malignancy within 5 years before enrollment 10.Pregnancy or lactation or refuse effective birth control method 11.Subject with herbal, supplements or steroids (except topical steroid) at least 7 days consecutively; or on other investigational drugs within 4 weeks before enrolment 12.Subject who is allergic to whey protein isolate (WPI), soy protein isolate, fish oil (except diarrhea from lactose intolerance)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Statistical different of HbA1C level at baseline and day91. Baseline & day 91 significant level of 0.05 | — |
Secondary
| Measure | Time frame |
|---|---|
| Statistical different of 2-hour postprandial plasma glucose of reference food and Gen-Premium, and p Baseline & day 91 significant level of 0.05 | — |
Contacts
Public ContactApussanee Boonyaworakul
Royal Thai Army Medical Department
Outcome results
None listed