UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001588 |
|---|---|
| Receipt number | 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 09:20:10 |
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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
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
sfukumoto@med.osaka-cu.ac.jp
Sponsor or person
Institute
4C-study Research Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001910
