UMIN-CTR Clinical Trial

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

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Basic information

Public 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

Acronym

Study on the effectiveness of 111-lunchbox dietary method as a new dietary regimen for calorie-restricted diets in diabetes treatment. (111-lunchbox study)

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

Scientific Title:Acronym

Study on the effectiveness of 111-lunchbox dietary method as a new dietary regimen for calorie-restricted diets in diabetes treatment. (111-lunchbox study)

Region

Japan


Condition

Condition

Type 2 diabetes mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify the effectiveness of 111-lunchbox dietary method as a self-learning procedure for easy dietary treatment of diabetes.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Glycemic control status (HbA1C)

Key secondary outcomes

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


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

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.

Interventions/Control_2

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.

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

40 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

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.

Key exclusion criteria

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.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshiki Nishizawa

Organization

Osaka City University Graduate School of Medicine

Division name

Department of Metabolism, Endocrinology and Molecular Medicine

Zip code


Address

1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585, Japan

TEL

06-6645-3806

Email



Public contact

Name of contact person

1st name
Middle name
Last name Shinya Fukumoto

Organization

Osaka City University Graduate School of Medicine

Division name

Department of Metabolism, Endocrinology and Molecular Medicine

Zip code


Address

1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585, Japan

TEL

06-6645-3806

Homepage URL


Email



Sponsor or person

Institute

111-lunchbox Study Group

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2010 Year 04 Month 28 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2010 Year 04 Month 20 Day

Date of IRB


Anticipated trial start date

2010 Year 06 Month 01 Day

Last follow-up date

2012 Year 10 Month 15 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 04 Month 15 Day

Last modified on

2012 Year 10 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004233


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name