UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016484 |
|---|---|
| Receipt number | R000019099 |
| Scientific Title | Effect of Carbohydrate Intake Ratio on the QOL of Patients with Type 2 Diabetes |
| Date of disclosure of the study information | 2015/02/16 |
| Last modified on | 2025/02/17 15:28:45 |
* 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
Effect of Carbohydrate Intake Ratio on the QOL of Patients with Type 2 Diabetes
Acronym
Effect of Carbohydrate Intake Ratio on the QOL of Patients with Type 2 Diabetes
Scientific Title
Effect of Carbohydrate Intake Ratio on the QOL of Patients with Type 2 Diabetes
Scientific Title:Acronym
Effect of Carbohydrate Intake Ratio on the QOL of Patients with Type 2 Diabetes
Region
| Japan |
Condition
Condition
Type 2 Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study was conducted to verify the effect of carbohydrate intake ratio(50% or 60%) on the QOL of Patients with type 2 diabetes.
Basic objectives2
Others
Basic objectives -Others
Japan Diabetes Society suggested that the carbohydrate intake ratio of patients with type 2 diabetes must be 50-60% in their recommendation in March 2013. Furthermore general practitioner should consider of the safety of diet therapy, food culture of Japan, ndividual taste for food and QOL. There are few Intervention study in carbohydrate intake ratio in Japan. We think that verification of the effect of carbohydrate intake ratio on the QOL of Patients with type 2 diabetes is very important and have high clinical value.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
QOL(DTR-QOL) (at the time of entry, and at 6 and 12 month after)
Key secondary outcomes
1) HbA1c, Fasting plasma glucose
2) Serum Lipid(TC,TG,HDL-C,LDL-C)
3) urine albumin
4) Body Weight, Body Mass Index
5) Problem Areas in Diabetes Survey(PAID)
6) Brief-type Self -administered Diet History Questionnaire(BDHQ)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
carbohydrate intake ratio 50%
Interventions/Control_2
carbohydrate intake ratio 60%
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patient with type2 diabetes who has not received nutrition education for diabetes within the past 6 months.
2) HbA1c 8.0%<= and 14%>
Key exclusion criteria
1) Patient suffer from diabetic ketosis, diabetic coma within the past 6 months.
2) Patient with severe infection, severe injury, before and after operation.
3) Patient with over diabetic nephropathy stage 3, and aCKD stage3.
4) Serum creatinine 1.5mg/dl<= within past 2 month.
5) Patient with severe liver dysfunction.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadashi Yamakawa |
Organization
Yokohama City University Medical Center
Division name
Department of endocrinology & metabolism
Zip code
Address
4-57, Urahunecho, Minami-ku, Yokohama-shi, Kanagawa, 232-0024, Japan
TEL
045-261-5656
yamakat@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichiro Takahashi |
Organization
Yokohama City University Medical Center
Division name
Department of endocrinology & metabolism
Zip code
Address
4-57, Urahunecho, Minami-ku, Yokohama-shi, Kanagawa, 232-0024, Japan
TEL
045-261-5656
Homepage URL
ken5073@yokohama-cu.ac.jp
Sponsor or person
Institute
Department of Biostatistics and Epidemiology,
Yokohama City University Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
横浜市立大学附属市民総合医療センター（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 16 | 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
| 2015 | Year | 01 | Month | 30 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 09 | Day |
Last modified on
| 2025 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019099
