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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003064
Receipt No. R000003687
Scientific Title An open label, randomized control study on the effectiveness of the Lanchonmat Method vs. the Food Exchange List Method as a diet therapy in type 2 diabetic patients.
Date of disclosure of the study information 2010/01/20
Last modified on 2011/03/31

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Basic information
Public title An open label, randomized control study on the effectiveness of the Lanchonmat Method vs. the Food Exchange List Method as a diet therapy in type 2 diabetic patients.

Acronym The Lanchonmat Method vs. the Food Exchange List Method Study.

Scientific Title An open label, randomized control study on the effectiveness of the Lanchonmat Method vs. the Food Exchange List Method as a diet therapy in type 2 diabetic patients.

Scientific Title:Acronym The Lanchonmat Method vs. the Food Exchange List Method Study.

Region
Japan

Condition
Condition Type 2 Diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the effectiveness of Place-mat with a food exchange list as
a dietary management in type 2 diabetic patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Diabetic Control (HbA1c)
Key secondary outcomes Metabolic parameter (Cholesterol, Blood Glucose etc ),
Psychological parameter, Energy intake

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Lanchonmat Method Group;
A nationally registerd dietitian guides a diet therapy exercising the Lanchonmat Method.
Guidance are four times during the 6-month study period.
Interventions/Control_2 Food Exchange List Method Group;
A nationally registerd dietitian guides a diet therapy exercising the Food Exchange List Method.
Guidance are four times 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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patients more than Age 20 with type 2 diabetes mellitus
2.Patients with first diet therapy
3.Outpatients
4.Patients whose written informed consents are obtained
Key exclusion criteria 1. Blood pressure >= 200 / 120 mmHg on drug therapy
2.Type 1 Diabetes patients
3.anti-GAD antibody +
4.Patients with renal failure ( blood creatinine >= 2.0 (men) , 1.5
(wemen) mg/dL
5.Pregnant women, nursing women, or possible pregnant.
6.Other patients judged unsuitable by the attending physician.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name TAKAMURA Toshinari
Organization Kanazawa University Graduate School of Medical Science
Division name Department of Disease Control and Homeostasis
Zip code
Address 13-1 Takara-machi, Kanazawa, Ishikawa
TEL 0762652000
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yumie TAKESHITA
Organization Kanazawa University Graduate School of Medical Science
Division name Department of Disease Control and Homeostasis
Zip code
Address 13-1 Takara-machi, Kanazawa, Ishikawa
TEL 0762652000
Homepage URL http://www.teamdiet.jp/crnet/
Email teamdiet@gmail.com

Sponsor
Institute Kanazawa University
Institute
Department

Funding Source
Organization Kanazawa University

Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor NPO Team DiET
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 金沢大学附属病院

Other administrative information
Date of disclosure of the study information
2010 Year 01 Month 20 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 Open public recruiting
Date of protocol fixation
2009 Year 12 Month 10 Day
Date of IRB
Anticipated trial start date
2009 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 01 Month 20 Day
Last modified on
2011 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003687

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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