UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003064 |
|---|---|
| Receipt number | 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 14:10:51 |
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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
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/
teamdiet@gmail.com
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003687
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
