UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002179 |
|---|---|
| Receipt number | R000002678 |
| Scientific Title | Comparative study on the degree of caloric restriction of diet as a dietary treatment for obese patients with type 2 diabetes: a multi-center prospective, randomized, comparative study |
| Date of disclosure of the study information | 2009/07/10 |
| Last modified on | 2011/08/15 14:28:56 |
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Basic information
Public title
Comparative study on the degree of caloric restriction of diet as a dietary treatment for obese patients with type 2 diabetes: a multi-center prospective, randomized, comparative study
Acronym
25 or 30 Study
Scientific Title
Comparative study on the degree of caloric restriction of diet as a dietary treatment for obese patients with type 2 diabetes: a multi-center prospective, randomized, comparative study
Scientific Title:Acronym
25 or 30 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 compare the effectiveness of caloric restriction of 25 kcal/IBW/day diet vs. 30 kcal/IBW/day diet as a dietary treatment for obese patients with type 2 diabetes
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Body weight
Key secondary outcomes
1. Glycemic control status (HbA1c, FPG)
2. Lipid profile (LDL-C, HDL-C, TG)
3. Liver function (AST,ALT,r-GTP)
4. Continuation and performance of dietary treatment (energy intake)
5. Satisfaction and psychological complaints (questionnaire survey)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
25 kcal/IBW/day group:
A nationally registered dietitian guides a calorie-restricted diet of 25 kcal/IBW/day. Periodic instruction is repeated during the 1-year study period.
Interventions/Control_2
30 kcal/IBW/day group:
A nationally registered dietitian guides a calorie-restricted diet of 30 kcal/IBW/day. Periodic instruction is repeated during the 1-year 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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Patients with type 2 diabetes mellitus.
2.BMI 25 or more.
3.Age, 20 to 80.
4.Patients after obtaining written informed consent.
Key exclusion criteria
1.Pregnant or lactating women.
2.Patients who have a severe hepatic or renal dysfunction.
3.Patients who are on a low protein diet.
4.Patients who are in DKA state.
5.Patients who are 3 kg weight loss within 3 months.
6.Patients whom doctors in charge judge as inappropriate for the inclusion.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuo Terauchi |
Organization
Graduate School of Medicine, Yokohama City University
Division name
Department of Endocrinology and Metabolism
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiyomi Masuda |
Organization
Graduate School of Medicine, Yokohama City University
Division name
Department of Endocrinology and Metabolism
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
Homepage URL
Sponsor or person
Institute
Graduate School of Medicine, Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
No
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
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
| 2009 | Year | 07 | Month | 10 | 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
| 2008 | Year | 11 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 07 | Month | 10 | Day |
Last modified on
| 2011 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002678
