type 2 diabetes
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: New Japanese outpatients with type 2 diabetes and HbA1c levels of 6.5% or above at Haimoto Clinic who do not take any type of oral hypoglycemic agent, insulin or steroid hormone from 3 months before baseline.
Exclusion criteria
Exclusion criteria: Taking any type of oral hypoglycemic agent, insulin or steroid hormone from 3 months before baseline that would impact HbA1c levels; following strict carbohydrate restriction at baseline based on commercial diet therapies such as the Atkins diet; serum creatinine levels greater than 2.0 mg/dl, ketoacidosis, soft drink ketosis, cancer or decompensatory liver cirrhosis and alcoholic fatty liver disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BMI and visceral fat by CT and CT value in the liver and spleen, macronutrients and carbohydrate sources based on dietary records at baseline and 6 months, and the association of changes in carbohydrate sources with changes in the above parameters. | — |
Secondary
| Measure | Time frame |
|---|---|
| Insulin, HOMA-IR and serum lipid profile at baseline and 6 months later | — |
Countries
Japan
Contacts
Haimoto Clinic Department of Internal Medicine