UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002179
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email

Sponsor
Institute Graduate School of Medicine, Yokohama City University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002678

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.