Type 2 diabetes
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Has been diagnosed with Type 2 Diabetes HbA1c(NGSP) is more than 6.5% and not more than 9.5%.
Exclusion criteria
Exclusion criteria: Those whose HbA1c has worsen by more than 1% over the last 3 months, and/or has failed to reach treatment goals and assessed to need immediate care. Those who are undergoing intensive care for cardiovascular, cerebrovascular and kindney disease. Those who are participating in other interventional clinical trials. Those for other reasons, who are decided as inadequate for subjects by their doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c (baseline, Nutrition education 1st, 2nd, 3rd, 4th) HbA1c, the upper limit of the bilateral 95% CI: below the 0.40% pre-defined as the non-inferiority margin. | — |
Secondary
| Measure | Time frame |
|---|---|
| BMI, % body fat, blood pressure, diet behavior, nutrient intake (baseline, Nutrition education 1st, 2nd, 3rd, 4th) | — |
Countries
Japan
Contacts
Tokushima University Diabetes Therapeutics and Research Center