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


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 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


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

Value
https://center6.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