Unique ID issued by UMIN | UMIN000003494 |
---|---|
Receipt number | R000004233 |
Scientific Title | An open-label, randomized, controlled, parallel-group comparative study on the effectiveness of 111-lunchbox dietary method as a dietary management in type 2 diabetic patients |
Date of disclosure of the study information | 2010/04/28 |
Last modified on | 2012/10/15 09:18:07 |
An open-label, randomized, controlled, parallel-group comparative study on the effectiveness of 111-lunchbox dietary method as a dietary management in type 2 diabetic patients
Study on the effectiveness of 111-lunchbox dietary method as a new dietary regimen for calorie-restricted diets in diabetes treatment. (111-lunchbox study)
An open-label, randomized, controlled, parallel-group comparative study on the effectiveness of 111-lunchbox dietary method as a dietary management in type 2 diabetic patients
Study on the effectiveness of 111-lunchbox dietary method as a new dietary regimen for calorie-restricted diets in diabetes treatment. (111-lunchbox study)
Japan |
Type 2 diabetes mellitus
Endocrinology and Metabolism |
Others
NO
To verify the effectiveness of 111-lunchbox dietary method as a self-learning procedure for easy dietary treatment of diabetes.
Efficacy
Glycemic control status (HbA1C)
1.Body weight, BMI
2.Other measures of glycemic status (FPG, 1,5-AG, IRI, rate of achievement of glycemic goal (HbA1c < 7.0 or < 6.5%))
3.Lipid profile
4.Proteinuria/Albuminuria
5.Intake survey
6.Level of satisfaction with therapy, QOL (questionnaire survey)
7.Adherence
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
NO
2
Treatment
Behavior,custom |
111-lunchbox group:
In addition to the conventional dietary treatment, 111-lunchbox dietary method is guided by nationally registered dietitian.
Periodic guidance is repeated during the 6-month study period.
Conventional dietary treatment group:
Continuing conventional calorie-restricted diets of 25-30 kcal/IBW/day using a food exchange list guided by nationally registered dietitian.
Periodic guidance is repeated during the 6-month study period.
40 | years-old | <= |
80 | years-old | > |
Male and Female
1.Patients with type 2 diabetes mellitus.
2.Age 40 to less than 80 years.
3.Undergoing dietary treatment
4.Patients with HbA1c of 6.0-9.0% at entry.
5.No initiation or changes in hypoglycemic drugs or antidyslipidemic drugs within the 2-month period preceding initiation of the study.
1.Complication by stage 3B or more severe diabetic nephropathy, or stage 3 or more severe chronic kidney disease (CKD) not associated with diabetes.
2.Malignant or acute disease.
3.Severe liver disease.
4.Decreased pancreatic function due to chronic pancreatitis, etc.
5.Past history of surgery of the gastrointestinal tract or complication by gastrointestinal disease requiring dietary restriction.
6.Heart failure.
7.Pregnant or lactating women
8.Under steroid treatment
9.Patient judged to have difficulty in performing dietetics on his/her own due to dementia, etc.
10.Other patients judged unsuitable by the attending physician.
60
1st name | |
Middle name | |
Last name | Yoshiki Nishizawa |
Osaka City University Graduate School of Medicine
Department of Metabolism, Endocrinology and Molecular Medicine
1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
06-6645-3806
1st name | |
Middle name | |
Last name | Shinya Fukumoto |
Osaka City University Graduate School of Medicine
Department of Metabolism, Endocrinology and Molecular Medicine
1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
06-6645-3806
111-lunchbox Study Group
None
Self funding
NO
2010 | Year | 04 | Month | 28 | Day |
Unpublished
Completed
2010 | Year | 04 | Month | 20 | Day |
2010 | Year | 06 | Month | 01 | Day |
2012 | Year | 10 | Month | 15 | Day |
2010 | Year | 04 | Month | 15 | Day |
2012 | Year | 10 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004233