Type 2 diabetes mellitus
Conditions
Interventions
To replace everyday meals with nutritionally balanced home-delivered ones (test meals) once daily
To have everyday meals
Sponsors
Osaka University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Outpatients with type 2 diabetes mellitus who have increased body mass index (>= 25 kg/m2) or increased waist circumference (>= 85 cm in males and >= 90 cm in females) and require weight reduction
Exclusion criteria
Exclusion criteria: - People for whom test meals are not medically appropriate (e.g., people with renal failure, those with hepatic failure, those with food allergy, and those with intense activity and greater nutritional needs) - People who are unable to prepare test meals as directed - People who are scheduled to have a long trip or in-hospital treatment during the study period - People in whom anti-diabetic or anti-obesity medications will be started, changed, or stopped during the study period - People with a pacemaker - People participating in another clinical trial - People whose participation in this clinical trial is considered inappropriate by their attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in body weight at 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| - Percent change in body weight at 6 weeks - Change in waist circumference at 6 and 12 weeks - Change in hemoglobin A1c levels at 6 and 12 weeks - Change in diet-related quality of life at 6 and 12 weeks | — |
Countries
Japan
Contacts
Public ContactToshihiko Shiraiwa
Shiraiwa Medical Clinic Shiraiwa Medical Clinic
Outcome results
None listed