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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001588
Receipt No. R000001910
Scientific Title An open-label, multicenter, randomized, controlled, parallel-group comparative study on the effectiveness of carbohydrate-counting and calorie-counting as a dietary management in type 2 diabetic patients treated without insulin therapy
Date of disclosure of the study information 2008/12/25
Last modified on 2012/10/15

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Basic information
Public title An open-label, multicenter, randomized, controlled, parallel-group comparative study on the effectiveness of carbohydrate-counting and calorie-counting as a dietary management in type 2 diabetic patients treated without insulin therapy
Acronym Carbohydrate Counting and Calorie Counting study of dietary management in type 2 diabetic patients without insulin therapy (4C study)
Scientific Title An open-label, multicenter, randomized, controlled, parallel-group comparative study on the effectiveness of carbohydrate-counting and calorie-counting as a dietary management in type 2 diabetic patients treated without insulin therapy
Scientific Title:Acronym Carbohydrate Counting and Calorie Counting study of dietary management in type 2 diabetic patients without insulin therapy (4C 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 carbohydrate-counting focusing on amount of carbohydrate and calorie-counting with a food exchange list mainly focusing on nutrient balance and energy restriction as a dietary management in type 2 diabetic patients treated without insulin therapy.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Glycemic control status (HbA1c)
Key secondary outcomes 1. Other measures of glycemic status (FPG, 1,5-AG, IRI, rate of achievement of glycemic goal (HbA1c < 7.0 or < 6.5%))
2. Body weight, BMI
3. Lipid profile (LDL, HDL, TG, FFA, etc.)
4. Albuminuria
5. Level of continuation and performance of dietary management (intake energy and nutrition survey)
6. Level of satisfaction with therapy, QOL (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 YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Calorie-counting group:
A nationally registered dietitian guides a calorie-restricted diet of 25-30 kcal/IBW/day using a food exchange list. Periodic guidance is repeated during the 6-month study period.
Manuals for each dietary intervention are provided and methods of guidance are shared among facilities.
Interventions/Control_2 Carbohydrate-counting group:
A nationally registered dietitian guides a diet using criteria according to which carbohydrate amount is correspond to 50-60% of a 25-30 kcal/IBW/day diet. Periodic guidance is repeated during the 6-month study period.
Manuals for each dietary intervention are provided and methods of guidance are shared among facilities.
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
70 years-old >
Gender Male and Female
Key inclusion criteria 1. Patients with type 2 diabetes mellitus.
2. Age 20 to less than 70 years.
3. Under treatment with no antidiabetic agents, or with oral hypoglycemic drugs.
4. Not undergoing dietary intervention during the 6-month period prior to initiation of the study.
5. Patients with HbA1c of 6.5-10.0% at entry.
6. No initiation or changes in hypoglycemic drugs or antidyslipidemic drugs within the 3-month period preceding initiation of the study.
Key exclusion criteria 1. Complication by stage 3B or more severe diabetic nephropathy, or stage 3 or more severe chronic kidney disease (CKD) not associated with diabetes.
2. Malignant or acute disease.
3. Severe liver disease.
4. Decreased pancreatic function due to chronic pancreatitis, etc.
5. Past history of surgery of the gastrointestinal tract or complication by gastrointestinal disease requiring dietary restriction.
6. Heart failure.
7. Pregnant or lactating women
8. Under insulin treatment
9. Under steroid treatment
10. Patient judged to have difficulty in performing dietetics on his/her own due to dementia, etc.
11. Other patients judged unsuitable by the attending physician.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiki Nishizawa
Organization Osaka City University Graduate School of Medicine
Division name Department of Metabolism, Endocrinology and Molecular Medicine
Zip code
Address 1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL 06-6645-3806
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shinya Fukumoto
Organization Osaka City University Graduate School of Medicine
Division name Department of Metabolism, Endocrinology and Molecular Medicine
Zip code
Address 1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL 06-6645-3806
Homepage URL
Email sfukumoto@med.osaka-cu.ac.jp

Sponsor
Institute 4C-study Research Group

Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization None

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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
2008 Year 12 Month 25 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 12 Month 11 Day
Date of IRB
Anticipated trial start date
2009 Year 01 Month 01 Day
Last follow-up date
2012 Year 09 Month 01 Day
Date of closure to data entry
2012 Year 12 Month 01 Day
Date trial data considered complete
2013 Year 03 Month 01 Day
Date analysis concluded
2013 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 12 Month 18 Day
Last modified on
2012 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001910

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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